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PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study in patients with atrial fibrillation: Rationale, design and methods
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.
Trial registration: ClinicalTrials.gov NCT03053843.