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Análisis de datos de la cohorte retrospectiva Alzira 2012-2021" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3957 "Ancho" => 3184 "Tamanyo" => 491859 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Kaplan–Meier curves at one, 2 and 5 years in patients with delirium vs. without delirium (<span class="elsevierStyleItalic">La Ribera University Hospital</span>).</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Daniela Villalón Rubio, Elisa García Tercero, Jesús López Gómez, Hugo González, Ángel Belenguer Varea, Cristina Cunha-Pérez, Miguel Germán Borda, Francisco José Tarazona-Santabalbina" "autores" => array:8 [ 0 => array:2 [ "nombre" => "Daniela Villalón" "apellidos" => "Rubio" ] 1 => array:2 [ "nombre" => "Elisa García" "apellidos" => "Tercero" ] 2 => array:2 [ "nombre" => "Jesús López" "apellidos" => "Gómez" ] 3 => array:2 [ "nombre" => "Hugo" "apellidos" => "González" ] 4 => array:2 [ "nombre" => "Ángel Belenguer" "apellidos" => "Varea" ] 5 => array:2 [ "nombre" => "Cristina" "apellidos" => "Cunha-Pérez" ] 6 => array:2 [ "nombre" => "Miguel Germán" "apellidos" => "Borda" ] 7 => array:2 [ "nombre" => "Francisco José" "apellidos" => "Tarazona-Santabalbina" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0211139X24001057?idApp=UINPBA00004N" "url" => "/0211139X/unassign/S0211139X24001057/v1_202409230415/en/main.assets" ] "itemAnterior" => array:17 [ "pii" => "S0211139X2400074X" "issn" => "0211139X" "doi" => "10.1016/j.regg.2024.101540" "estado" => "S100" "fechaPublicacion" => "2024-07-24" "aid" => "101540" "copyright" => "SEGG" "documento" => "article" "crossmark" => 0 "subdocumento" => "rev" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "es" => array:12 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Revisión</span>" "titulo" => "Efectos de la intergeneracionalidad (relaciones, contactos y programas) en la reducción del edadismo: una revisión sistemática (2013-2023)" "tienePdf" => "es" "tieneTextoCompleto" => "es" "tieneResumen" => array:2 [ 0 => "es" 1 => "en" ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "«Effects of intergenerationality (relationships, contacts and programmes) on reducing ageism: A systematic review (2013-2023)»" ] ] "contieneResumen" => array:2 [ "es" => true "en" => true ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figura 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1330 "Ancho" => 2684 "Tamanyo" => 128979 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Evolución de la producción científica. Fuente: elaboración propia.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Esther Sánchez Sánchez, Inmaculada Montero García" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Esther" "apellidos" => "Sánchez Sánchez" ] 1 => array:2 [ "nombre" => "Inmaculada" "apellidos" => "Montero García" ] ] ] ] ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0211139X2400074X?idApp=UINPBA00004N" "url" => "/0211139X/unassign/S0211139X2400074X/v1_202407240435/es/main.assets" ] "en" => array:21 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original article</span>" "titulo" => "Justification and design of the BOCADOS-IC study: Nutritional management in adults followed in Spanish hospitals for heart failure" "tieneTextoCompleto" => true "autores" => array:2 [ 0 => array:4 [ "autoresLista" => "Alberto Esteban-Fernández, Juan Luis Bonilla-Palomas, Ana Ayesta López, José Ángel Pérez-Rivera" "autores" => array:5 [ 0 => array:3 [ "nombre" => "Alberto" "apellidos" => "Esteban-Fernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 1 => array:3 [ "nombre" => "Juan Luis" "apellidos" => "Bonilla-Palomas" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Ana Ayesta" "apellidos" => "López" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:4 [ "nombre" => "José Ángel" "apellidos" => "Pérez-Rivera" "email" => array:1 [ 0 => "jangel.perezrivera@gmail.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">e</span>" "identificador" => "aff0025" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 4 => array:2 [ "colaborador" => "on behalf of the BOCADOS-IC study researchers" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">◊</span>" "identificador" => "fn0005" ] ] ] ] "afiliaciones" => array:5 [ 0 => array:3 [ "entidad" => "Cardiology Service, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Cardiology Service, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Cardiology Service, Hospital Universitario Central de Asturias, Oviedo, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Cardiology Service, Hospital Universitario de Burgos, Burgos, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "Faculty of Health Sciences, Universidad Isabel I, Burgos, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] 1 => array:2 [ "autoresLista" => "Rocío Ayala Muñoz, Marta Cobo Marcos, Pablo Díez Villanueva, José Manuel García Pinilla, Josebe Goirigolzarri Artaza, César Jiménez Méndez, Carolina Ortiz Cortés, Teresa Pérez Sanz, Carolina Robles Gamboa, Miguel Rodríguez Santamarta, Mikel Taibo Urquía, David Vaqueriza Cubillo" "autores" => array:13 [ 0 => array:1 [ "colaborador" => "Annex. Members of the BOCADOS-IC group" ] 1 => array:2 [ "nombre" => "Rocío Ayala" "apellidos" => "Muñoz" ] 2 => array:2 [ "nombre" => "Marta Cobo" "apellidos" => "Marcos" ] 3 => array:2 [ "nombre" => "Pablo Díez" "apellidos" => "Villanueva" ] 4 => array:2 [ "nombre" => "José Manuel García" "apellidos" => "Pinilla" ] 5 => array:2 [ "nombre" => "Josebe Goirigolzarri" "apellidos" => "Artaza" ] 6 => array:2 [ "nombre" => "César Jiménez" "apellidos" => "Méndez" ] 7 => array:2 [ "nombre" => "Carolina Ortiz" "apellidos" => "Cortés" ] 8 => array:2 [ "nombre" => "Teresa Pérez" "apellidos" => "Sanz" ] 9 => array:2 [ "nombre" => "Carolina Robles" "apellidos" => "Gamboa" ] 10 => array:2 [ "nombre" => "Miguel Rodríguez" "apellidos" => "Santamarta" ] 11 => array:2 [ "nombre" => "Mikel Taibo" "apellidos" => "Urquía" ] 12 => array:2 [ "nombre" => "David Vaqueriza" "apellidos" => "Cubillo" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Justificación y diseño del estudio BOCADOS-IC: manejo nutricional en adultos seguidos en hospitales españoles por insuficiencia cardiaca" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 934 "Ancho" => 1800 "Tamanyo" => 207717 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Summary of the inclusion and follow-up criteria in the BOCADOS study.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Malnutrition is a common disorder in patients with heart failure (HF), with a prevalence of between 8 and 57%, depending on the degree of severity of HF.<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">1,2</span></a> Several studies have shown that the presence of malnutrition increases mortality in these patients compared to those with adequate nutritional status, especially if frailty is associated.<a class="elsevierStyleCrossRefs" href="#bib0125"><span class="elsevierStyleSup">3,4</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">The presence of malnutrition in patients with HF has a multifactorial aetiology, with hormonal dysregulation and neurohormonal and inflammatory activation typical of the disease, producing an anabolic–catabolic imbalance in favour of catabolism. In addition, altered appetite, reduced intake and malabsorption have been observed in these patients, contributing to the onset of malnutrition.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Clinical practice guidelines recommend screening for malnutrition in HF patients but do not recommend specific interventions, as there is limited evidence on the impact of nutritional intervention in reducing major events in this setting.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">6</span></a> The detection of malnutrition is particularly relevant in patients with acute HF as, in this clinical setting, nutritional intervention has been shown to reduce the risk of readmission for HF and all-cause death.<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">7–10</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">However, evidence in the outpatient setting is limited, although its presence, especially in older patients, has been shown to have a prognostic impact.<a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">11</span></a> In the FRAGIC registry, which included older patients with HF in the outpatient setting, almost 50% of patients had frailty. When associated with malnutrition, detected with the <span class="elsevierStyleItalic">Mini Nutritional Assessment-Short Form</span> (MNA-SF) screening scale, mortality was 2.5 times higher.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">12</span></a></p><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Justification and relevance of the study</span><p id="par0025" class="elsevierStylePara elsevierViewall">The presence of malnutrition is a predictor of poor prognosis in patients with HF in the outpatient setting, especially in older patients. However, there is a lack of evidence on the potential benefit of a specific nutritional intervention.</p><p id="par0030" class="elsevierStylePara elsevierViewall">This study hypothesises that a reproducible nutritional intervention conducted in cardiology consultations, together with the general recommendations for HF patients, could improve medium-term morbidity and mortality in patients with chronic HF who are undernourished.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Objectives</span><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Primary objective:</span> To assess the effect on the combined event of 6-month all-cause mortality or HF admission of nutritional intervention in undernourished patients with chronic stable HF.</p><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Secondary objectives:</span><p id="par0040" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0045" class="elsevierStylePara elsevierViewall">To assess the effect on the components of the primary endpoint separately.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0050" class="elsevierStylePara elsevierViewall">To assess the effect on cardiovascular (CV) mortality at 6 months.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0055" class="elsevierStylePara elsevierViewall">To assess the effect on all-cause admission at 6 months.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0060" class="elsevierStylePara elsevierViewall">To assess changes in quality of life 3 and 6 months after the intervention.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0065" class="elsevierStylePara elsevierViewall">To assess changes in nutritional status at 3 and 6 months after the intervention.</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0070" class="elsevierStylePara elsevierViewall">To assess changes in anthropometric variables at 3 and 6 months after the intervention.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">•</span><p id="par0075" class="elsevierStylePara elsevierViewall">To assess differences in NT-proBNP at 6 months after the intervention.</p></li></ul></p></span></span></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Methods</span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Design of the study</span><p id="par0080" class="elsevierStylePara elsevierViewall">This is a pragmatic, randomised, controlled, masked, open-label, prospective, multicentre, pragmatic clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic HF in the outpatient setting (Central illustration).</p><p id="par0085" class="elsevierStylePara elsevierViewall">This study involves 15 Spanish hospitals with an organisational structure for the care of HF patients, with a recruitment period of 6 months. Patients with chronic outpatient HF are randomised to the intervention group (multifactorial nutritional intervention) or the control group (standard follow-up). The maximum follow-up is 6 months, so the total duration of the study is estimated to be 12 months. At the initial visit and follow-up period (at 3 months and 6 months), a clinical, anthropometric and analytical assessment coincides with routine patient visits to the Cardiology HF clinic by telephone or consulting the patient's electronic medical records.</p><p id="par0090" class="elsevierStylePara elsevierViewall">The study protocol has been evaluated and approved by the XXX2 research ethics committee (reference 2921). All participating centres inform their respective ethics committees of participation in this trial.</p><p id="par0095" class="elsevierStylePara elsevierViewall">The study is included in the <span class="elsevierStyleItalic">US</span><span class="elsevierStyleItalic">National Institute of Health database</span> (reference XXX3) and has been approved by the Research Agency of the Spanish Society of Cardiology (SSC). All patients receive verbal and written information about the study and sign the informed consent document to be included. Patients dependent on activities of daily living or with some degree of cognitive impairment may participate in the study if they are institutionalised or have adequate family support. In these cases, the informed consent shall also be signed by the person responsible for the patient or his/her legal representative.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Pragmatic trial</span><p id="par0100" class="elsevierStylePara elsevierViewall">Pragmatic clinical trials are conducted under normal conditions to provide results more applicable to clinical practice and decision-making. The appropriateness of the objective pursued by the XXX1 study (<span class="elsevierStyleItalic">nutritional management in adults followed in Spanish hospitals for heart failure</span>) was assessed using the nine domains of the PRECIS-2 tool to increase external validity<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">13</span></a>:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">1.</span><p id="par0105" class="elsevierStylePara elsevierViewall">Eligibility. Exclusion criteria are primarily limited to formal contraindications to nutritional supplementation. No specific restrictions are present, and the inclusion criteria are flexible in that any patient with ambulatory HF and criteria for malnutrition or risk of malnutrition is eligible.</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">2.</span><p id="par0110" class="elsevierStylePara elsevierViewall">Recruitment. Participants are recruited during their routine visits to the HF unit in the Cardiology Departments of the participating centres. No supplementary resources or advertising are used for recruitment.</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">3.</span><p id="par0115" class="elsevierStylePara elsevierViewall">Scope. Scope identical to that of usual care.</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">4.</span><p id="par0120" class="elsevierStylePara elsevierViewall">Organisation. Participants receive information cards; a telephone system is available to answer their questions.</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">5.</span><p id="par0125" class="elsevierStylePara elsevierViewall">Flexibility (treatment delivery). Total flexibility, being the nutritional intervention adaptable and individualised.</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">6.</span><p id="par0130" class="elsevierStylePara elsevierViewall">Flexibility (compliance). The importance of adherence to treatment and following the recommendations provided is reinforced at each consultation visit. No other measures to improve adherence are implemented.</p></li><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">7.</span><p id="par0135" class="elsevierStylePara elsevierViewall">Follow-up. Participants receive the same follow-up as with usual care.</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">8.</span><p id="par0140" class="elsevierStylePara elsevierViewall">Primary endpoint. The primary endpoint is the time to the occurrence of death from any cause or admission for HF, which are critical events in the natural history of the disease. Secondary endpoints also include CV mortality.</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">9.</span><p id="par0145" class="elsevierStylePara elsevierViewall">Principal analysis. The primary analysis applies the “intention-to-treat” principle to the entire dataset, regardless of compliance.</p></li></ul></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Low-level intervention trial</span><p id="par0150" class="elsevierStylePara elsevierViewall">The XXX1 study is a trial promoted by the Section of Geriatric Cardiology of the SSC, with no financial participation from private organisations. The data owners are the study investigators and the promoting scientific organisation. None of the data obtained are exploited for commercial purposes.</p><p id="par0155" class="elsevierStylePara elsevierViewall">On the other hand, it can be considered a trial with a low level of intervention, as it does not consider the use of any specific medication. In the intervention group, patients undergo specialised medical follow-up based on dietary recommendations, physical exercise and oral supplementation in some cases, as recommended by different public bodies (Dietary and nutritional recommendations of the Madrid Health Service of 2013 and Process of Care for Patients with Malnutrition in Aragon of the Government of Aragon of 2019). The prescription of nutritional supplements is at the treating physician's discretion according to their clinical criteria and the recommendations of the clinical practice guidelines for the care of patients at risk of malnutrition. Supplements are usually indicated for patients with comorbidity, advanced age, and the need for hydrosaline restriction. They are recommended to be hyperproteic, low in protein, low in calories, and low in sodium.</p><p id="par0160" class="elsevierStylePara elsevierViewall">Recommendations on diet and exercise are included in the HF clinical practice guidelines.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">6</span></a> The safety of a comprehensive approach to malnutrition in HF patients has already been proven in the much more complex scenario of admission for decompensation.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">1</span></a> Complementary diagnostic or follow-up procedures do not pose an additional risk or burden to the safety of the participating subjects.</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Recruitment</span><p id="par0165" class="elsevierStylePara elsevierViewall">Patients are recruited at any outpatient visit to the Cardiology HF units of the participating centres at any time once it has been confirmed that they meet the inclusion criteria and have no exclusion criteria. Given that there is more evidence of the favourable effects of nutritional support in patients with malnutrition than in those at risk of malnutrition, recruitment is expected to be limited to 20% of the total, with an MNA-SF score between 7 and 11 points. Once this cut-off has been reached globally, no more patients at risk of malnutrition can be included, continuing only with the recruitment of patients with MNA-SF<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>7 points. A cut-off analysis is predefined 3 months after inclusion to analyse the inclusion rate so that if the number of patients is lower than expected (less than 80% of those expected), the inclusion period will be extended by 3 months.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Study population</span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Inclusion criteria</span><p id="par0170" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">•</span><p id="par0175" class="elsevierStylePara elsevierViewall">Patients<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>65 years old and able to sign the informed consent form.</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">•</span><p id="par0180" class="elsevierStylePara elsevierViewall">Previous diagnosis of HF, under follow-up in an outpatient clinic of the Cardiology service.</p></li><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">•</span><p id="par0185" class="elsevierStylePara elsevierViewall">Presence of malnutrition: MNA-SF screening score of 11 points or less.</p></li></ul></p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Exclusion criteria</span><p id="par0190" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">•</span><p id="par0195" class="elsevierStylePara elsevierViewall">An episode of HF decompensation in the last month.</p></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">•</span><p id="par0200" class="elsevierStylePara elsevierViewall">Presence of severe comorbidity: severe functional or cognitive impairment (GDS<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>6, Barthel<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>40–55 or CFS scale 7–8) or chronic kidney disease in dialysis programme.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">•</span><p id="par0205" class="elsevierStylePara elsevierViewall">Patients with established nutritional support are included in other trials or studies related to the nutritional approach.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">•</span><p id="par0210" class="elsevierStylePara elsevierViewall">Life expectancy of less than 6 months due to another non-cardiological problem.</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">•</span><p id="par0215" class="elsevierStylePara elsevierViewall">Patients do not give informed consent or refuse nutritional assessment or support.</p></li></ul></p></span></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Heart failure diagnosis</span><p id="par0220" class="elsevierStylePara elsevierViewall">Diagnosis of HF is made according to clinical practice guidelines, based on left ventricular systolic dysfunction or diastolic dysfunction and elevated natriuretic peptides.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">6</span></a> Patients with HF and reduced (<40%), mildly reduced (41–49%) and preserved (>50%) left ventricular function (LVEF) are included.</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Nutritional study</span><p id="par0225" class="elsevierStylePara elsevierViewall">The diagnosis of malnutrition is established according to the screening results based on the MNA-SF scale, which includes 6 headings. This is a general nutritional assessment survey designed and validated to provide a simple and rapid assessment of the patient's nutritional status, allowing the detection of malnourished or those at risk of malnutrition.<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">14</span></a> A final score is obtained that classifies the subject into three categories: well-nourished (≥12 points), at risk of malnutrition (8–11 points) and malnourished (≤7 points). This tool includes the aspects recommended for diagnosing malnutrition15 and has been used previously in clinical intervention trials in patients with HF.<a class="elsevierStyleCrossRefs" href="#bib0165"><span class="elsevierStyleSup">11,16</span></a> In addition to providing a rapid screening for malnutrition, the MNA scale allows for identifying more severe patients. In this aspect and HF patients, it is superior to the <span class="elsevierStyleItalic">Global Leadership Initiative on Malnutrition</span> (GLIM) criteria for diagnosing malnutrition.<a class="elsevierStyleCrossRefs" href="#bib0195"><span class="elsevierStyleSup">17,18</span></a></p><p id="par0230" class="elsevierStylePara elsevierViewall">A nutritional study is performed using biochemical parameters (albumin, prealbumin, transferrin, total cholesterol and lymphocytes) and anthropometric parameters (body mass index (BMI), tricipital fold, as an indicator of fat tissue, and arm muscle circumference, as an indicator of muscle tissue). Anthropometric measurements are obtained according to standardised methodology.<a class="elsevierStyleCrossRefs" href="#bib0205"><span class="elsevierStyleSup">19,20</span></a> Weight and height are recorded with the patient barefoot and in light clothing on a scale with a measuring rod. For measuring the tricipital fold, a Holtain plicometer with an accuracy of 0.2<span class="elsevierStyleHsp" style=""></span>mm and a pressure of 10<span class="elsevierStyleHsp" style=""></span>g/mm<span class="elsevierStyleSup">2</span> shall be used. A tape measure calibrated in millimetres shall be used to measure mid-brachial circumference. BMI shall be obtained using the formula: body mass index<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>weight/height<span class="elsevierStyleSup">2</span> (kg/m<span class="elsevierStyleSup">2</span>). Arm muscle circumference shall be obtained using the Jelliffe equation<a class="elsevierStyleCrossRef" href="#bib0215"><span class="elsevierStyleSup">21</span></a>: arm muscle circumference<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>midbrachial circumference<span class="elsevierStyleHsp" style=""></span>−<span class="elsevierStyleHsp" style=""></span>(<span class="elsevierStyleItalic">π</span><span class="elsevierStyleHsp" style=""></span>×<span class="elsevierStyleHsp" style=""></span>triceps crease), expressed in cm.</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Quality of life and geriatric syndromes</span><p id="par0235" class="elsevierStylePara elsevierViewall">According to the methodology used in other studies in elderly patients with HF,<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">12</span></a> comorbidity is assessed with the Charlson index, quality of life with the <span class="elsevierStyleItalic">Minnesota Living With Heart Failure Questionnaire</span> scale, frailty with the FRAIL scale, sarcopenia with the screening SARC-F scale and dependence for activities of daily living with the Barthel index.</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Randomisation and intervention</span><p id="par0240" class="elsevierStylePara elsevierViewall">After confirming the inclusion criteria, through a simple randomisation process, patients are assigned to the control or intervention groups using a computer programme standard for all participating centres (<a class="elsevierStyleCrossRef" href="#fig0010">Fig. 1</a>).</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0245" class="elsevierStylePara elsevierViewall">Patients in the control group undergo the standard follow-up performed in the HF unit, with recommendations for self-care and general HF health education according to the usual clinical practice of each centre. Physical exercise and a balanced diet rich in vegetables, cereals, olive oil and low in salt and fat are recommended for all HF patients.</p><p id="par0250" class="elsevierStylePara elsevierViewall">Patients in the intervention group undergo an individualised nutritional intervention programme comprising:<ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">•</span><p id="par0255" class="elsevierStylePara elsevierViewall">Dietary optimisation and specific recommendations: nutritional recommendation material specific to the malnourished HF patient (<a class="elsevierStyleCrossRef" href="#sec0145">Supplementary Material 1</a>) is given and explained to each patient.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">•</span><p id="par0260" class="elsevierStylePara elsevierViewall">The initiation of nutritional supplementation is suggested if any of these situations occur<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">5,22</span></a>:</p></li><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">∘</span><p id="par0265" class="elsevierStylePara elsevierViewall">At the treating physician's discretion, they consider that nutritional requirements are not being met.</p></li><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">∘</span><p id="par0270" class="elsevierStylePara elsevierViewall">Patients with malnutrition (MNA-SF<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>7).</p></li><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">∘</span><p id="par0275" class="elsevierStylePara elsevierViewall">BMI<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>20<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span> and/or weight loss<span class="elsevierStyleHsp" style=""></span>><span class="elsevierStyleHsp" style=""></span>20% in the last 6 months.</p></li><li class="elsevierStyleListItem" id="lsti0150"><span class="elsevierStyleLabel">∘</span><p id="par0280" class="elsevierStylePara elsevierViewall">Patients who are expected to have difficulty following a regular oral diet (social problems, swallowing problems, refusal to eat, etc.) but in whom oral supplementation is possible.</p></li></ul></p><p id="par0285" class="elsevierStylePara elsevierViewall">The initiation of oral supplements is not a requirement of the study, so not all patients in the intervention group need to receive them, even if they meet the abovementioned characteristics. Their use is advised in such situations, but it is always the treating physician's decision according to their clinical judgement and the pre-existing internal protocols of each health centre. Low-sodium and volume-restricted supplements should be chosen if it is decided to initiate supplements. In addition, supplements are adapted if the patient has diabetes (low carbohydrate content) or has renal insufficiency (less protein).</p><p id="par0290" class="elsevierStylePara elsevierViewall">Patients in the intervention group receive a fortnightly telephone call to ensure adherence and reinforce dietary recommendations. At the discretion of the responsible cardiologist, these patients may be referred to a specific nutrition consultation.</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Overcrossing and exclusion from the study</span><p id="par0295" class="elsevierStylePara elsevierViewall">Any change of group (discontinuation or initiation of the nutritional intervention or any of its components) may be carried out by the medical staff responsible for the patient's care, under their responsibility. Patients and the physicians responsible for them are asked to contact the central scientific committee to discuss the group change before deciding.</p><p id="par0300" class="elsevierStylePara elsevierViewall">Patients who switch groups remain in the trial and are followed up according to the protocol. As the study's primary endpoint is based on the intention-to-treat principle, patients are analysed according to randomisation, irrespective of group changes. The ex-post analysis considers group changes and analyses patients who remain in the original randomisation group throughout the follow-up of the study.</p><p id="par0305" class="elsevierStylePara elsevierViewall">Given that this is an open-label study (unblinded to treatment), with an intervention routinely used in daily medical practice, and that crossovers are not a criterion for the withdrawal of a patient from the study, the only reason for the exclusion of a patient from the study is the patient's willingness to be withdrawn from the trial.</p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Monitoring protocol and events</span><p id="par0310" class="elsevierStylePara elsevierViewall">Following standard clinical practice, two follow-up visits have been established at 3 and 6 months, which may be carried out in person, by telephone or through the digitalised clinical history. The follow-up is carried out in each centre, ensuring adherence to the “arm” of the study (nutritional intervention or standard follow-up).</p><p id="par0315" class="elsevierStylePara elsevierViewall">At the baseline visit, the inclusion and exclusion criteria are checked, informed consent is collected, and the patient is randomised. In addition, demographic data and the most significant medical history are collected. A nutritional (MNA-SF and SRC-F scales) and biometric assessment is performed at the baseline and two follow-up visits (3 and 6 months). A comprehensive geriatric assessment (frailty, dependence and quality of life) and a clinical and analytical assessment are also performed. In addition, a survey of nutritional habits and therapeutic adherence is carried out in the follow-up and fortnightly telephone nursing visits in the intervention group. The list of variables is provided in <a class="elsevierStyleCrossRef" href="#sec0145">Supplementary Material 2</a>.</p><p id="par0320" class="elsevierStylePara elsevierViewall">Suppose a local investigator identifies that a patient has been admitted for any event potentially relevant to the study. In that case, they collect the corresponding information and send it blinded to the coordinating centre to adjudicate events by a committee independent of the study.</p></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Evaluation of outcome variables</span><p id="par0325" class="elsevierStylePara elsevierViewall">To assess the primary endpoint, the primary study endpoint is the time to the combined event of death from any cause or readmission for HF. All deaths reported after randomisation are analysed, except deaths in patients who have withdrawn consent. Deaths are subclassified according to their primary cause into: (a) death of CV origin (deaths resulting from AMI, sudden cardiac death, death from HF progression, death from stroke, death from CV procedures, death from CV haemorrhage, and death from other CV causes) and death of non-CV origin (includes death of unknown cause). A hospital stay of more than 24<span class="elsevierStyleHsp" style=""></span>h due to the appearance of signs and/or symptoms of HF decompensation (for this purpose, a stay of more than 24<span class="elsevierStyleHsp" style=""></span>h in the emergency department is also considered a hospital admission).</p><p id="par0330" class="elsevierStylePara elsevierViewall">For the assessment of secondary endpoints, the following are studied during follow-up: (a) time to death from any cause; (b) time to death from CV causes; (c) time to readmission for HF; (d) time to admission for any cause; (e) reduction of NTproBNP at 6 months; (f) change in the quality of life with the Minnesota scale; (g) change in nutritional status with the MNA-SF scale and other nutritional parameters.</p><p id="par0335" class="elsevierStylePara elsevierViewall">To analyse the safety objectives, a complete clinical and analytical interview is carried out at 3 and 6 months, including possible side effects of the intervention and the dropout rate. The main side effects described for the nutritional supplements are mild digestive symptoms, which are questioned explicitly during the clinical interview, and mild alterations in ionic, hydrocarbon and lipid metabolism, which are studied in the analytical determinations.</p><p id="par0340" class="elsevierStylePara elsevierViewall">Efficacy and safety targets are assigned by a non-study committee blinded to the treatment group. The chairperson's vote shall prevail in case of disagreement among the committee members.</p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Statistical analysis</span><p id="par0345" class="elsevierStylePara elsevierViewall">Quantitative variables are expressed as mean and standard deviation or median and interquartile range, according to the variable's characteristics and the distribution's normality (analysed using the Kolmogorov–Smirnov test). Qualitative variables are expressed as numbers and percentages. Differences between groups in qualitative variables are analysed using the Chi-square test and, in the case of quantitative variables, the Student's <span class="elsevierStyleItalic">t</span>-test or Mann–Whitney <span class="elsevierStyleItalic">U</span>-test, depending on the distribution of the variable.</p><p id="par0350" class="elsevierStylePara elsevierViewall">The Kaplan–Meier method is used for survival analysis, using the log-rank test to compare survival distributions. The clinical impact assessment is evaluated by calculating the number of patients needing treatment. A multivariate Cox proportional hazards model is developed, considering time to event as the dependent variable, with variables entered into the model using a sequential procedure. Variables with a higher clinical relevance and those with a significance<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.01 in the univariate analysis are included.</p><p id="par0355" class="elsevierStylePara elsevierViewall">In all tests, a <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>0.05 was considered to determine the existence of statistically significant differences. SPSS® version 20.0 (SPSS Inc.; Chicago, Illinois, USA) and STATA 17.0 (Texas, USA) are used.</p><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Sample size</span><p id="par0360" class="elsevierStylePara elsevierViewall">For the calculation of the sample size, the combined event of death from any cause or readmission for HF at 1-year follow-up was considered, according to data from the PICNIC study.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">1</span></a> For an estimated annual incidence of the event in the control group of 60% and a relative reduction of 50% of the primary endpoint in the intervention group, with a power of 80% and an alpha error with the bilateral test of 0.05, assuming a 10% loss to follow-up, a sample size of 266 patients followed for 6 months is estimated to detect the desired effect.</p></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Pre-specified subgroups</span><p id="par0365" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0030"><li class="elsevierStyleListItem" id="lsti0155"><span class="elsevierStyleLabel">•</span><p id="par0370" class="elsevierStylePara elsevierViewall">By age: over and under 80 years old.</p></li><li class="elsevierStyleListItem" id="lsti0160"><span class="elsevierStyleLabel">•</span><p id="par0375" class="elsevierStylePara elsevierViewall">According to sex: men and women.</p></li><li class="elsevierStyleListItem" id="lsti0165"><span class="elsevierStyleLabel">•</span><p id="par0380" class="elsevierStylePara elsevierViewall">By degree of malnutrition according to the MNA-SF scale: at-risk/malnutrition.</p></li><li class="elsevierStyleListItem" id="lsti0170"><span class="elsevierStyleLabel">•</span><p id="par0385" class="elsevierStylePara elsevierViewall">According to LVEF, it is less than or equal to 40% and greater than 40%.</p></li></ul></p></span></span></span><span id="sec0115" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Discussion</span><p id="par0390" class="elsevierStylePara elsevierViewall">Malnutrition has been identified as a marker of poor prognosis in HF patients, especially older patients, but few interventional studies have evaluated whether nutritional intervention modifies prognosis. HF guidelines do not make specific recommendations in this regard.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">6</span></a> In a recent review, Esteban-Fernandez et al. recommend early detection of malnutrition with a multimodal approach, which could favour early intervention,<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">5</span></a> although evidence of its benefit is limited.</p><p id="par0395" class="elsevierStylePara elsevierViewall">In the inpatient setting, the PICNIC trial, a randomised controlled intervention trial involving 120 malnourished patients during an HF admission, found that nutritional intervention reduced the occurrence of the primary combined event of all-cause death and HF admission by 65% during the 12-month follow-up.<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">7</span></a> However, no randomised studies have evaluated the benefit of nutritional intervention in the outpatient setting.</p><p id="par0400" class="elsevierStylePara elsevierViewall">The XXX1 trial is a randomised, masked, prospective study which aims to evaluate, in a 6-month follow-up, the impact of nutritional intervention in patients with chronic HF in whom the MNA-SF scale detects malnutrition in specific HF consultations. The main contributions of this trial could be: (a) to demonstrate that the benefit of nutritional intervention also extends to patients with HF in the outpatient setting; (b) that simple, individualised nutritional intervention, but without the need for the development of complex programmes or approaches, can modify nutritional status and have an impact on the prognosis of patients; (c) that early diagnosis of malnutrition should be incorporated into the regular assessment of HF patients and management algorithms should be developed, to improve the survival of these patients; (d) describe the clinical characteristics of malnourished patients with HF and their evolution during follow-up.</p></span><span id="sec0120" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Conclusions</span><p id="par0405" class="elsevierStylePara elsevierViewall">Malnutrition is a common comorbidity in patients with ambulatory HF, which has been related to worse morbidity and mortality. There is little evidence of the benefit of nutritional intervention in chronic outpatient patients. The XXX1 trial allows us to delve deeper into these aspects and evaluate the prognostic impact of nutritional intervention in malnourished patients with HF.</p></span><span id="sec0125" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0180">Source of funding</span><p id="par0410" class="elsevierStylePara elsevierViewall">This study is supported by a grant for research projects in the field of <span class="elsevierStyleGrantSponsor" id="gs1">Heart Failure Association</span> (<span class="elsevierStyleGrantNumber" refid="gs1">SECAINC-INV-ICC 23/04</span>).</p></span><span id="sec0130" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0185">Contributions from the authors</span><p id="par0415" class="elsevierStylePara elsevierViewall">Conception and design: AEF, JLBP, JAPR; Development: AEF; Review and acceptance: all authors.</p></span><span id="sec0135" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0190">Conflicts of interest</span><p id="par0420" class="elsevierStylePara elsevierViewall">AEF, JLBP and JAPR have received payments from Fresenius Krabi for scientific speaking fees.</p></span><span id="sec0140" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0195">Uncited reference</span><p id="par0425" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#bib0185">15</a>.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:15 [ 0 => array:3 [ "identificador" => "xres2241879" "titulo" => "Abstract" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1875656" "titulo" => 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"identificador" => "sec0030" "titulo" => "Design of the study" ] 1 => array:2 [ "identificador" => "sec0035" "titulo" => "Pragmatic trial" ] 2 => array:2 [ "identificador" => "sec0040" "titulo" => "Low-level intervention trial" ] 3 => array:2 [ "identificador" => "sec0045" "titulo" => "Recruitment" ] 4 => array:3 [ "identificador" => "sec0050" "titulo" => "Study population" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0055" "titulo" => "Inclusion criteria" ] 1 => array:2 [ "identificador" => "sec0060" "titulo" => "Exclusion criteria" ] ] ] 5 => array:2 [ "identificador" => "sec0065" "titulo" => "Heart failure diagnosis" ] 6 => array:2 [ "identificador" => "sec0070" "titulo" => "Nutritional study" ] 7 => array:2 [ "identificador" => "sec0075" "titulo" => "Quality of life and geriatric syndromes" ] 8 => array:2 [ "identificador" => "sec0080" "titulo" => "Randomisation and intervention" ] 9 => array:2 [ "identificador" => "sec0085" "titulo" => "Overcrossing and exclusion from the study" ] 10 => array:2 [ "identificador" => "sec0090" "titulo" => "Monitoring protocol and events" ] 11 => array:2 [ "identificador" => "sec0095" "titulo" => "Evaluation of outcome variables" ] 12 => array:3 [ "identificador" => "sec0100" "titulo" => "Statistical analysis" "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0105" "titulo" => "Sample size" ] 1 => array:2 [ "identificador" => "sec0110" "titulo" => "Pre-specified subgroups" ] ] ] ] ] 7 => array:2 [ "identificador" => "sec0115" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0120" "titulo" => "Conclusions" ] 9 => array:2 [ "identificador" => "sec0125" "titulo" => "Source of funding" ] 10 => array:2 [ "identificador" => "sec0130" "titulo" => "Contributions from the authors" ] 11 => array:2 [ "identificador" => "sec0135" "titulo" => "Conflicts of interest" ] 12 => array:2 [ "identificador" => "sec0140" "titulo" => "Uncited reference" ] 13 => array:2 [ "identificador" => "xack773165" "titulo" => "Acknowledgement" ] 14 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2024-07-02" "fechaAceptado" => "2024-09-04" "PalabrasClave" => array:2 [ "en" => array:2 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1875656" "palabras" => array:4 [ 0 => "Heart failure" 1 => "Malnutrition" 2 => "Nutritional intervention" 3 => "Elderly patient" ] ] 1 => array:4 [ "clase" => "abr" "titulo" => "Abbreviations" "identificador" => "xpalclavsec1875658" "palabras" => array:5 [ 0 => "XXX1" 1 => "CV" 2 => "HF" 3 => "MNA-SF" 4 => "SSC" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1875657" "palabras" => array:4 [ 0 => "Insuficiencia cardiaca" 1 => "Desnutrición" 2 => "Intervención nutricional" 3 => "Paciente anciano" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction and objectives</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Malnutrition is common in patients with heart failure (HF) and is associated with increased mortality and hospital admissions. There is evidence that nutritional intervention in the inpatient setting improves the prognosis, but evidence in the outpatient setting is limited. This study aims to assess whether a nutritional intervention in outpatients with HF and malnutrition produces a benefit in their morbidity and mortality.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">XXX1 (<span class="elsevierStyleItalic">Nutritional Assessment in Adults followed in Spanish hospitals for Heart Failure</span>) is a randomised, controlled, masked, prospective, multicentre, clinical trial that includes patients with HF followed on an outpatient basis and who present malnutrition by the screening <span class="elsevierStyleItalic">Mini Nutritional Assessment-Short Form</span> (MNA-SF) scale. Patients are randomised to a control group (standard follow-up) or the intervention group (multifactorial nutritional intervention). A sample size of 266 patients has been estimated, with a follow-up of 6 months. The primary endpoint is time to death from any cause or admission for HF. The analysis is performed on an intention-to-treat basis.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Conclusions</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">The XXX1 trial aims to evaluate the impact of nutritional intervention in malnourished patients with HF in the outpatient setting.</p></span>" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction and objectives" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Introducción y objetivos</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La desnutrición es frecuente en los pacientes con insuficiencia cardíaca (IC), y se asocia con un aumento de la mortalidad y de los ingresos hospitalarios. Existen pruebas de que la intervención nutricional en el ámbito hospitalario mejora el pronóstico, pero las pruebas en el ámbito ambulatorio son limitadas. Este estudio pretende evaluar si una intervención nutricional en pacientes ambulatorios con IC y desnutrición produce un beneficio en su morbimortalidad.</p></span> <span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Métodos</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">El ensayo XXX1 «Valoración nutricional en adultos seguidos en hospitales españoles por insuficiencia cardiaca» es un ensayo clínico aleatorizado, controlado, enmascarado, prospectivo y multicéntrico, que incluye pacientes con IC seguidos de forma ambulatoria, y que presentan desnutrición mediante la escala de cribado Mini Nutritional Assessment-Short Form (MNA-SF). Los pacientes se asignan aleatoriamente a un grupo de control (seguimiento estándar) o al grupo de intervención (intervención nutricional multifactorial). Se ha estimado un tamaño muestral de 266 pacientes, con un seguimiento de 6 meses. El criterio de valoración primario es el tiempo transcurrido hasta la muerte por cualquier causa o el ingreso por IC. El análisis se realiza por intención de tratar.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Conclusiones</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">El ensayo XXX1 pretende evaluar el impacto de la intervención nutricional en los pacientes desnutridos con IC en el ámbito ambulatorio.</p></span>" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "abst0020" "titulo" => "Introducción y objetivos" ] 1 => array:2 [ "identificador" => "abst0025" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0030" "titulo" => "Conclusiones" ] ] ] ] "NotaPie" => array:2 [ 0 => array:3 [ "etiqueta" => "◊" "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Please see a list of the members of the BOCADOS-IC group in <a class="elsevierStyleCrossRef" href="#sec0145">Appendix A</a>.</p>" "identificador" => "fn0005" ] 1 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">XXX1: BOCADOS-IC; XXX2: Hospital Universitario de Burgos; XXX3: <span class="elsevierStyleInterRef" id="intr0005" href="ctgov:NCT05923138">NCT05923138</span>.</p>" ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:2 [ 0 => array:4 [ "apendice" => "<p id="par0435" class="elsevierStylePara elsevierViewall">Rocío Ayala Muñoz, Marta Cobo Marcos, Pablo Díez Villanueva, José Manuel García Pinilla, Josebe Goirigolzarri Artaza, César Jiménez Méndez, Carolina Ortiz Cortés, Teresa Pérez Sanz, Carolina Robles Gamboa, Miguel Rodríguez Santamarta, Mikel Taibo Urquía, David Vaqueriza Cubillo.</p>" "etiqueta" => "Appendix A" "titulo" => "Researchers of the BOCADOS-IC study" "identificador" => "sec0145" ] 1 => array:4 [ "apendice" => "<p id="par0445" class="elsevierStylePara elsevierViewall">The following are the supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia><elsevierMultimedia ident="upi0010"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia></p>" "etiqueta" => "Appendix B" "titulo" => "Supplementary data" "identificador" => "sec0155" ] ] ] ] "multimedia" => array:4 [ 0 => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 934 "Ancho" => 1800 "Tamanyo" => 207717 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Summary of the inclusion and follow-up criteria in the BOCADOS study.</p>" ] ] 1 => array:5 [ "identificador" => "upi0005" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc1.doc" "ficheroTamanyo" => 54272 ] ] 2 => array:5 [ "identificador" => "upi0010" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc2.doc" "ficheroTamanyo" => 31744 ] ] 3 => array:5 [ "identificador" => "fig0005" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => false "mostrarDisplay" => true "figura" => array:1 [ 0 => array:4 [ "imagen" => "mmc3.jpeg" "Alto" => 841 "Ancho" => 1500 "Tamanyo" => 135653 ] ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:22 [ 0 => array:3 [ "identificador" => "bib0115" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Impact of malnutrition on long-term mortality in hospitalized patients with heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "J.L. Bonilla-Palomas" 1 => "A.L. Gámez-López" 2 => "M.P. Anguita-Sánchez" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Rev Esp Cardiol" "fecha" => "2011" "volumen" => "64" "paginaInicial" => "752" "paginaFinal" => "758" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0120" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Malnutrition, congestion and mortality in ambulatory patients with heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "S. Sze" 1 => "P. Pellicori" 2 => "J. Zhang" 3 => "A.L. Clark" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1136/heartjnl-2018-313312" "Revista" => array:6 [ "tituloSerie" => "Heart" "fecha" => "2019" "volumen" => "105" "paginaInicial" => "297" "paginaFinal" => "306" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/30121635" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0125" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Cardiac cachexia: a systematic overview" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "S. von Haehling" 1 => "M. Lainscak" 2 => "J. Springer" 3 => "S.D. Anker" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.pharmthera.2008.09.009" "Revista" => array:6 [ "tituloSerie" => "Pharmacol Ther" "fecha" => "2009" "volumen" => "121" "paginaInicial" => "227" "paginaFinal" => "252" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/19061914" "web" => "Medline" ] ] ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib0130" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Clinical significance of nutritional status in patients with chronic heart failure – a systematic review" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "A. Wawrzeńczyk" 1 => "M. Anaszewicz" 2 => "A. Wawrzeńczyk" 3 => "J. Budzyński" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1007/s10741-019-09793-2" "Revista" => array:6 [ "tituloSerie" => "Heart Fail Rev" "fecha" => "2019" "volumen" => "24" "paginaInicial" => "671" "paginaFinal" => "700" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/31016426" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0135" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Diagnosis and management of malnutrition in patients with heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "A. Esteban-Fernández" 1 => "R. Villar-Taibo" 2 => "M. Alejo" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:3 [ "tituloSerie" => "J Clin Med" "fecha" => "2023" "volumen" => "12" ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib0140" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "T.A. McDonagh" 1 => "M. Metra" 2 => "M. Adamo" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1093/eurheartj/ehab368" "Revista" => array:6 [ "tituloSerie" => "Eur Heart J" "fecha" => "2021" "volumen" => "42" "paginaInicial" => "3599" "paginaFinal" => "3726" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/34447992" "web" => "Medline" ] ] ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib0145" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Nutritional intervention in malnourished hospitalized patients with heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "J.L. Bonilla-Palomas" 1 => "A.L. Gámez-López" 2 => "J.C. Castillo-Domínguez" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.arcmed.2016.11.005" "Revista" => array:6 [ "tituloSerie" => "Arch Med Res" "fecha" => "2016" "volumen" => "47" "paginaInicial" => "535" "paginaFinal" => "540" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/28262195" "web" => "Medline" ] ] ] ] ] ] ] ] 7 => array:3 [ "identificador" => "bib0150" "etiqueta" => "8" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Readmission and mortality in malnourished, older, hospitalized adults treated with a specialized oral nutritional supplement: a randomized clinical trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "N.E. Deutz" 1 => "E.M. Matheson" 2 => "L.E. Matarese" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.clnu.2015.12.010" "Revista" => array:7 [ "tituloSerie" => "Clin Nutr" "fecha" => "2016" "volumen" => "35" "paginaInicial" => "18" "paginaFinal" => "26" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26797412" "web" => "Medline" ] ] "itemHostRev" => array:3 [ "pii" => "S2213177919307498" "estado" => "S300" "issn" => "22131779" ] ] ] ] ] ] ] 8 => array:3 [ "identificador" => "bib0155" "etiqueta" => "9" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Muscle wasting and cachexia in heart failure: mechanisms and therapies" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "S. Von Haehling" 1 => "N. Ebner" 2 => "M.R. Dos Santos" 3 => "J. Springer" 4 => "S.D. Anker" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1038/nrcardio.2017.51" "Revista" => array:6 [ "tituloSerie" => "Nat Rev Cardiol" "fecha" => "2017" "volumen" => "14" "paginaInicial" => "323" "paginaFinal" => "341" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/28436486" "web" => "Medline" ] ] ] ] ] ] ] ] 9 => array:3 [ "identificador" => "bib0160" "etiqueta" => "10" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Individualized nutritional support for hospitalized patients with chronic heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "L. Hersberger" 1 => "A. Dietz" 2 => "H. Bürgler" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.jacc.2021.03.232" "Revista" => array:6 [ "tituloSerie" => "J Am Coll Cardiol" "fecha" => "2021" "volumen" => "77" "paginaInicial" => "2307" "paginaFinal" => "2319" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/33958128" "web" => "Medline" ] ] ] ] ] ] ] ] 10 => array:3 [ "identificador" => "bib0165" "etiqueta" => "11" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Impact of malnutrition on long-term mortality in outpatients with chronic heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "J.L. Bonilla-Palomas" 1 => "A.L. Gámez-López" 2 => "M. Moreno-Conde" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.20960/nh.1131" "Revista" => array:6 [ "tituloSerie" => "Nutr Hosp" "fecha" => "2017" "volumen" => "34" "paginaInicial" => "1382" "paginaFinal" => "1389" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/29280655" "web" => "Medline" ] ] ] ] ] ] ] ] 11 => array:3 [ "identificador" => "bib0170" "etiqueta" => "12" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Frailty and prognosis of older patients with chronic heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "C. Jiménez-Méndez" 1 => "P. Díez-Villanueva" 2 => "C. Bonanad" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.rec.2022.04.016" "Revista" => array:6 [ "tituloSerie" => "Rev Esp Cardiol (Engl Ed)" "fecha" => "2022" "volumen" => "75" "paginaInicial" => "1011" "paginaFinal" => "1019" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/35718066" "web" => "Medline" ] ] ] ] ] ] ] ] 12 => array:3 [ "identificador" => "bib0175" "etiqueta" => "13" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The PRECIS-2 tool: designing trials that are fit for purpose" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "K. Loudon" 1 => "S. Treweek" 2 => "F. Sullivan" 3 => "P. Donnan" 4 => "K.E. Thorpe" 5 => "M. Zwarenstein" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:3 [ "tituloSerie" => "BMJ" "fecha" => "2015" "paginaInicial" => "350" ] ] ] ] ] ] 13 => array:3 [ "identificador" => "bib0180" "etiqueta" => "14" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Validation of the Mini Nutritional Assessment short-form (MNA®-SF): a practical tool for identification of nutritional status" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "M.J. Kaiser" 1 => "J.M. Bauer" 2 => "C. Ramsch" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "J Nutr Heal Aging" "fecha" => "2009" "volumen" => "13" "paginaInicial" => "782" "paginaFinal" => "788" ] ] ] ] ] ] 14 => array:3 [ "identificador" => "bib0185" "etiqueta" => "15" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "GLIM criteria for the diagnosis of malnutrition – a consensus report from the global clinical nutrition community" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "T. Cederholm" 1 => "G.L. Jensen" 2 => "M.I.T.D. Correia" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.clnu.2018.08.002" "Revista" => array:6 [ "tituloSerie" => "Clin Nutr" "fecha" => "2019" "volumen" => "38" "paginaInicial" => "1" "paginaFinal" => "9" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/30181091" "web" => "Medline" ] ] ] ] ] ] ] ] 15 => array:3 [ "identificador" => "bib0190" "etiqueta" => "16" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "J.R. Teerlink" 1 => "R. Diaz" 2 => "G.M. Felker" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1056/NEJMoa2025797" "Revista" => array:6 [ "tituloSerie" => "N Engl J Med" "fecha" => "2021" "volumen" => "384" "paginaInicial" => "105" "paginaFinal" => "116" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/33185990" "web" => "Medline" ] ] ] ] ] ] ] ] 16 => array:3 [ "identificador" => "bib0195" "etiqueta" => "17" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Nutritional status according to the GLIM criteria in patients with chronic heart failure: association with prognosis" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "C. Joaquín" 1 => "N. Alonso" 2 => "J. Lupón" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:4 [ "tituloSerie" => "Nutrients" "fecha" => "2022" "paginaInicial" => "14" "itemHostRev" => array:3 [ "pii" => "S0085253819310580" "estado" => "S300" "issn" => "00852538" ] ] ] ] ] ] ] 17 => array:3 [ "identificador" => "bib0200" "etiqueta" => "18" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Prediction of all-cause mortality with malnutrition assessed by nutritional screening and assessment tools in patients with heart failure: a systematic review" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "Y. Hu" 1 => "H. Yang" 2 => "Y. Zhou" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.numecd.2022.03.009" "Revista" => array:6 [ "tituloSerie" => "Nutr Metab Cardiovasc Dis" "fecha" => "2022" "volumen" => "32" "paginaInicial" => "1361" "paginaFinal" => "1374" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/35346547" "web" => "Medline" ] ] ] ] ] ] ] ] 18 => array:3 [ "identificador" => "bib0205" "etiqueta" => "19" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Assessment of protein energy malnutrition in older persons. Part II: Laboratory evaluation" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "M.L. Omran" 1 => "J.E. Morley" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Nutrition" "fecha" => "2000" "volumen" => "16" "paginaInicial" => "131" "paginaFinal" => "140" ] ] ] ] ] ] 19 => array:3 [ "identificador" => "bib0210" "etiqueta" => "20" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Assessment of protein energy malnutrition in older persons. Part I: History, examination, body composition, and screening tools" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "M.L. Omran" 1 => "J.E. Morley" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Nutrition" "fecha" => "2000" "volumen" => "16" "paginaInicial" => "50" "paginaFinal" => "63" ] ] ] ] ] ] 20 => array:3 [ "identificador" => "bib0215" "etiqueta" => "21" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Nutritional assessment in health programs" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "G. Christakis" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:3 [ "tituloSerie" => "Am J Public Health" "fecha" => "1973" "paginaInicial" => "63" ] ] ] ] ] ] 21 => array:3 [ "identificador" => "bib0220" "etiqueta" => "22" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Rationale and design of PICNIC study: nutritional intervention program in hospitalized patients with heart failure who are malnourished" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "A.L. Gámez-López" 1 => "J.L. Bonilla-Palomas" 2 => "M. Anguita-Sánchez" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1016/j.rec.2013.07.013" "Revista" => array:6 [ "tituloSerie" => "Rev Esp Cardiol (Engl Ed)" "fecha" => "2014" "volumen" => "67" "paginaInicial" => "277" "paginaFinal" => "282" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/24774590" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] "agradecimientos" => array:1 [ 0 => array:4 [ "identificador" => "xack773165" "titulo" => "Acknowledgement" "texto" => "<p id="par0430" class="elsevierStylePara elsevierViewall">To the Geriatric Cardiology Section of the SSC for the support provided.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/0211139X/unassign/S0211139X24001008/v1_202409160357/en/main.assets" "Apartado" => null "PDF" => "https://static.elsevier.es/multimedia/0211139X/unassign/S0211139X24001008/v1_202409160357/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0211139X24001008?idApp=UINPBA00004N" ]
Journal Information
Original article
Uncorrected Proof. Available online 16 September 2024
Justification and design of the BOCADOS-IC study: Nutritional management in adults followed in Spanish hospitals for heart failure
Justificación y diseño del estudio BOCADOS-IC: manejo nutricional en adultos seguidos en hospitales españoles por insuficiencia cardiaca
Alberto Esteban-Fernándeza, Juan Luis Bonilla-Palomasb, Ana Ayesta Lópezc, José Ángel Pérez-Riverad,e,
, on behalf of the BOCADOS-IC study researchers ◊
Corresponding author
a Cardiology Service, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain
b Cardiology Service, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain
c Cardiology Service, Hospital Universitario Central de Asturias, Oviedo, Spain
d Cardiology Service, Hospital Universitario de Burgos, Burgos, Spain
e Faculty of Health Sciences, Universidad Isabel I, Burgos, Spain
Annex. Members of the BOCADOS-IC group , Rocío Ayala Muñoz, Marta Cobo Marcos, Pablo Díez Villanueva, José Manuel García Pinilla, Josebe Goirigolzarri Artaza, César Jiménez Méndez, Carolina Ortiz Cortés, Teresa Pérez Sanz, Carolina Robles Gamboa, Miguel Rodríguez Santamarta, Mikel Taibo Urquía, David Vaqueriza Cubillo