Angeliki Papadaki1, Miguel Ángel Martínez-González2,3,4, Angel Alonso-Gómez3,5, Javier Rekondo3,5, Jordi Salas-Salvadó3,6, Dolores Corella3,7, Emilio Ros3,8, Montse Fitó3,9, Ramon Estruch3,10, José Lapetra3,11, Antonio García-Rodriguez12, Miquel Fiol3,13, Lluís Serra-Majem3,14, Xavier Pintó3,15, Miguel Ruiz-Canela2,3, Monica Bulló3,6, Mercè Serra-Mir3,8, Jose V Sorlí3,7, Fernando Arós3,5. 1. Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, UK. 2. University of Navarra, Department of Preventive Medicine and Public Health, Faculty of Medicine, IdiSNA, Pamplona, Spain. 3. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. 4. Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA. 5. Department of Cardiology, University Hospital Araba, Vitoria, Spain. 6. Human Nutrition Unit, Faculty of Medicine and Health Sciences, IISPV, Rovira i Virgili University, Reus, Spain. 7. Department of Preventive Medicine, University of Valencia, Valencia, Spain. 8. Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain. 9. Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. 10. Department of Internal Medicine, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain. 11. Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain. 12. Department of Preventive Medicine, University of Malaga, Malaga, Spain. 13. Palma Institut of Health Research (IdISPa), Hospital Son Espases, Palma de Mallorca, Spain. 14. Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Las Palmas, Spain. 15. Internal Medicine Department, Hospital Universitari de Bellvitge-IDIBELL, Universidad de Barcelona, Barcelona, Spain.
Abstract
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.
RCT Entities:
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.
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