title: Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial.
abstract: The aim of this study was to evaluate the effect of the Mediterranean diet (MedDiet) on the incidence of heart failure (HF), a pre-specified secondary outcome in the PREDIMED (PREvención con DIeta MEDiterránea) primary nutrition-intervention prevention trial.
  
  
  
  Participants at high risk of cardiovascular disease were randomly assigned to one of three diets: MedDiet supplemented with extra-virgin olive oil (EVOO), MedDiet supplemented with nuts, or a low-fat control diet. Incident HF was ascertained by a Committee for Adjudication of events blinded to group allocation. Among 7403 participants without prevalent HF followed for a median of 4.8 years, we observed 29 new HF cases in the MedDiet with EVOO group, 33 in the MedDiet with nuts group, and 32 in the control group. No significant association with HF incidence was found for the MedDiet with EVOO and MedDiet with nuts, compared with the control group [hazard ratio (HR) 0.68; 95% confidence interval (CI) 0.41-1.13, and HR 0.92; 95% CI 0.56-1.49, respectively].
  
  
  
  In this sample of adults at high cardiovascular risk, the MedDiet did not result in lower HF incidence. However, this pre-specified secondary analysis may have been underpowered to provide valid conclusions. Further randomized controlled trials with HF as a primary outcome are needed to better assess the effect of the MedDiet on HF risk.
  
  
  
  ISRCTN35739639.
authors.affiliation: Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, UK.
authors.forename: Angeliki
authors.initials: A
authors.lastname: Papadaki
authors.affiliation: University of Navarra, Department of Preventive Medicine and Public Health, Faculty of Medicine, IdiSNA, Pamplona, Spain.|CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Martínez-González
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Cardiology, University Hospital Araba, Vitoria, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Alonso-Gómez
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Cardiology, University Hospital Araba, Vitoria, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Rekondo
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Human Nutrition Unit, Faculty of Medicine and Health Sciences, IISPV, Rovira i Virgili University, Reus, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Salas-Salvadó
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Preventive Medicine, University of Valencia, Valencia, Spain.
authors.forename: Dolores
authors.initials: D
authors.lastname: Corella
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Ros
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.
authors.forename: Montse
authors.initials: M
authors.lastname: Fitó
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Internal Medicine, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Ramon
authors.initials: R
authors.lastname: Estruch
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Lapetra
authors.affiliation: Department of Preventive Medicine, University of Malaga, Malaga, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: García-Rodriguez
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Palma Institut of Health Research (IdISPa), Hospital Son Espases, Palma de Mallorca, Spain.
authors.forename: Miquel
authors.initials: M
authors.lastname: Fiol
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Las Palmas, Spain.
authors.forename: Lluís
authors.initials: L
authors.lastname: Serra-Majem
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Internal Medicine Department, Hospital Universitari de Bellvitge-IDIBELL, Universidad de Barcelona, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Pintó
authors.affiliation: University of Navarra, Department of Preventive Medicine and Public Health, Faculty of Medicine, IdiSNA, Pamplona, Spain.|CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Ruiz-Canela
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Human Nutrition Unit, Faculty of Medicine and Health Sciences, IISPV, Rovira i Virgili University, Reus, Spain.
authors.forename: Monica
authors.initials: M
authors.lastname: Bulló
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain.
authors.forename: Mercè
authors.initials: M
authors.lastname: Serra-Mir
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Preventive Medicine, University of Valencia, Valencia, Spain.
authors.forename: Jose V
authors.initials: JV
authors.lastname: Sorlí
authors.affiliation: CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.|Department of Cardiology, University Hospital Araba, Vitoria, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Arós
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control*; D038441:Diet, Mediterranean / Q000706:statistics & numerical data*; D019587:Dietary Supplements; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009754:Nuts; D000069463:Olive Oil; D010043:Outcome and Process Assessment, Health Care; D018570:Risk Assessment; D013223:Statistics as Topic
chemical_list: D000069463:Olive Oil
keywords: Cardiovascular disease; Heart failure; Mediterranean diet; PREDIMED study