PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study in patients with atrial fibrillation: Rationale, design and methods - 05/02/20

Doi : 10.1016/j.ahj.2019.10.009

MT Barrio-Lopez, MD, PhD ^a,^b,^{^{1
Equally contributed.}}, M Ruiz-Canela, MPH, PhD ^c,^d,^{^{1
Equally contributed.}}, P Ramos, MD ^e, L Tercedor, MD ^f,^g, JL Ibañez Criado, MD, PhD ^h, M Ortiz, PhD ^a,^b, L Goni, PhD ^c, A Ibañez Criado, MD ^h, R Macías-Ruiz, MD ^f, I García-Bolao, MD, PhD, FESC ^e, MA Martínez-González, MD, PhD, MPH ^c,^d,ⁱ, J Almendral, MD, PhD, FESC ^a,^b,^{^⁎}
^a Centro Integral de Enfermedades Cardiovasculares, Hospital Universitario HM Monteprincipe, HM Hospitales, University CEU-San Pablo, Madrid, Spain
^b Electrophysiology Laboratory and Arrhythmia Unit, Hospital Monteprincipe, Grupo HM Hospitales, University CEU-San Pablo, Madrid, Spain
^c Department of Preventive Medicine and Public Health, IDISNA (Instituto de Investigación Sanitaria de Navarra), University of Navarra, Pamplona, Spain
^d CIBER Fisiopatología de la Obesidad y Nutrición (CIBERObn), Instituto de Salud Carlos III, Madrid, Spain
^e Arrhythmia Unit, Department of Cardiology and Cardiac Surgery, Clinica Universidad de Navarra, Pamplona, Spain
^f Department of Cardiology, Virgen de las Nieves University Hospital, Av. Fuerzas Armadas s/n, Granada, Spain
^g Biosanitary Research Institute of Granada (ibs.GRANADA), Av. del Conocimiento s/n, Granada, Spain
^h Arrhythmia Unit, Cardiology Service, University General Hospital of Alicante, Alicante Institute of Health and Biomedical Research (ISABIAL-FISABIO Foundation), Alicante, Spain
ⁱ Department of Nutrition, Harvard TH Chan School of Public Health, Harvard University, Boston, USA

^⁎Reprint requests: Jesús Almendral, Centro Integral de Enfermedades Cardiovasculares. Hospital Universitario HM Montepríncipe. Av. de Montepríncipe, 25, 28660 Boadilla del Monte, Madrid, España.Centro Integral de Enfermedades CardiovascularesHospital Universitario HM Montepríncipe. Av. de Montepríncipe, 25Boadilla del MonteMadrid28660España

Background

Atrial fibrillation (AF) is the most common cardiac arrhythmia. Catheter ablation aims to restore sinus rhythm. However, relapses occur in up to 30% of patients. A Mediterranean diet (MedDiet) enriched with extra-virgin olive oil (EVOO) substantially reduced the incidence of AF in the PREDIMED trial. The PREDIMAR will test a similar intervention in secondary prevention.

Methods

PREDIMAR is a multicenter, randomized, single-blind trial testing the effect of a MedDiet enriched with EVOO to reduce tachyarrhythmia relapses after AF ablation. The primary outcome is the recurrence of any sustained atrial tachyarrhythmia after ablation (excluding those occurring only during the first 3 months after ablation). The target final sample size is 720 patients (360 per group) recruited from 4 Spanish hospitals. A remote intervention, maintained for 2 years, is delivered to the active intervention group including periodic phone calls by a dietitian and free provision of EVOO. The control group will receive delayed intervention after trial completion. Routine electrocardiogram (ECG) and Holter ECG are performed, and a portable cardiac rhythm monitoring device is provided to be worn by participants during 15 months.

Results

Recruitment started in March 2017. Up to July 2019, 609 patients were randomized (average inclusion rate: 5.3 patients/wk). Retention rates after 18 months are >94%.

Conclusions

If our hypothesis is confirmed, the utility of the MedDiet enriched with EVOO in slowing the progression of AF will be proven, preventing recurrences and potentially reducing complications.

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Plan

Methods

Design

Hypothesis and specific aims

Study population and recruitment

Interventions

Data and sample collection

Outcomes

Statistical analysis and sample size

RCT #NCT03053843.

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Vol 220

P. 127-136 - février 2020 Retour au numéro

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PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study in patients with atrial fibrillation: Rationale, design and methods - 05/02/20

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