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

Authors

  • Angeliki Papadaki,

    1. Centre for Exercise, Nutrition and Health Sciences, School for Policy Studies, University of Bristol, Bristol, UK
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  • Miguel Ángel Martínez-González,

    1. University of Navarra, Department of Preventive Medicine and Public Health, Faculty of Medicine, IdiSNA, Pamplona, Spain
    2. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    3. Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA
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  • Angel Alonso-Gómez,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Cardiology, University Hospital Araba, Vitoria, Spain
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  • Javier Rekondo,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Cardiology, University Hospital Araba, Vitoria, Spain
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  • Jordi Salas-Salvadó,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Human Nutrition Unit, Faculty of Medicine and Health Sciences, IISPV, Rovira i Virgili University, Reus, Spain
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  • Dolores Corella,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Preventive Medicine, University of Valencia, Valencia, Spain
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  • Emilio Ros,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain
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  • Montse Fitó,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain
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  • Ramon Estruch,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Internal Medicine, IDIBAPS, Hospital Clinic, University of Barcelona, Barcelona, Spain
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  • José Lapetra,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Family Medicine, Research Unit, Distrito Sanitario Atención Primaria Sevilla, Sevilla, Spain
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  • Antonio García-Rodriguez,

    1. Department of Preventive Medicine, University of Malaga, Malaga, Spain
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  • Miquel Fiol,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Palma Institut of Health Research (IdISPa), Hospital Son Espases, Palma de Mallorca, Spain
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  • Lluís Serra-Majem,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, Las Palmas, Spain
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  • Xavier Pintó,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Internal Medicine Department, Hospital Universitari de Bellvitge-IDIBELL, Universidad de Barcelona, Barcelona, Spain
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  • Miguel Ruiz-Canela,

    1. University of Navarra, Department of Preventive Medicine and Public Health, Faculty of Medicine, IdiSNA, Pamplona, Spain
    2. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
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  • Monica Bulló,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Human Nutrition Unit, Faculty of Medicine and Health Sciences, IISPV, Rovira i Virgili University, Reus, Spain
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  • Mercè Serra-Mir,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, University of Barcelona, Barcelona, Spain
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  • Jose V. Sorlí,

    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Preventive Medicine, University of Valencia, Valencia, Spain
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  • Fernando Arós

    Corresponding author
    1. CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (ISCIII), Madrid, Spain
    2. Department of Cardiology, University Hospital Araba, Vitoria, Spain
    • Corresponding author. Department of Cardiology, University Hospital Araba, c/ José Achotegui s/n. 01009 Vitoria-Gasteiz, Spain. Tel: +34 945007304, Fax: +34 945007359, Email: aborau@secardiologia.es

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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.

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