Mediterranean diet and risk of heart failure: Results from the PREDIMED randomized controlled trial

Angeliki Papadaki, Miguel Ángel Martínez-González, Angel Alonso-Gómez, Javier Rekondo, Jordi Salas-Salvadó, Dolores Corella, Emilio Ros, Montse Fitó, Ramon Estruch, José Lapetra, Antonio García-Rodriguez, Miquel Fiol, Lluís Serra-Majem, Xavier Pintó, Miguel Ruiz-Canela, Monica Bulló, Mercè Serra-Mir, Jose V. Sorlí, Fernando Arós*

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

70 Citations (Scopus)
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Aims: 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. Methods and results: 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]. Conclusion: 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. Trial registration: ISRCTN35739639.

Original languageEnglish
Pages (from-to)1179-1185
Number of pages7
JournalEuropean Journal of Heart Failure
Issue number9
Early online date30 Jan 2017
Publication statusPublished - Sept 2017

Bibliographical note

Acceptance email received 13/12/2016


  • AF, atrial fibrillation
  • BMI, body mass index
  • CHD, coronary heart disease
  • CVD, cardiovascular disease
  • EVOO, extra virgin olive oil
  • FFQ, food frequency questionnaire
  • HDL, high-density lipoprotein
  • HF, heart failure
  • LDL, low-density lipoprotein
  • MedDiet, Mediterranean diet
  • MI, myocardial infarction
  • PAD, peripheral arterial disease
  • PREDIMED, Prevención con Dieta Mediterránea
  • T2D, type 2 diabetes
  • WtHR, waist-to-height ratio


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