Atrial Fibrillation Clinical Trial
Official title:
Randomized Trial of Mediterranean Diet Plus Extravirgin Olive Oil in the Prevention of Recurrent Arrhythmias. The PREDIMAR (PREvención Con DIeta Mediterránea de Arritmias Recurrentes) Trial
Background: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and represents a
high priority public health problem, as in a few decades it will become a possibly
unsustainable load for the national health system. Preventive and therapeutic strategies
based on the best possible scientific evidence are required. Ablation therapy, despite being
the most effective approach, is associated with a 30-35% arrhythmic recurrence rate. An
intervention with Mediterranean diet and extra virgin olive oil (EVOO) has proven effective
in primary prevention and reduced the incidence of AF in high-risk subjects in a recent,
large, randomized trial (PREDIMED).
Methods: Parallel, randomized, multicenter nutritional intervention trial in 640 patients
with AF treated with catheter ablation. Two groups will be randomized in a 1:1 ratio: 1)
intervention with Mediterranean diet and EVOO; 2) usual care (control group). The primary
objective will be the incidence of atrial tachyarrhythmias for two years after ablation. At
least 190 recurrences are expected after 2 years (median) of follow-up. A relative risk of
0.7 is assumed and statistical power of 80%. Follow-up visits will be scheduled at 3, 6, 12,
18 and 24 months. In addition to the in-person visits, event monitors will be used to
document episodes. Dietary intervention will be carried out by nutritionists who will use
methods adapted from the PREDIMED trial with contacts every 2 months. 1 liter of EVOO per
week will be provided for free in the intervention arm. Inflammatory markers will be analyzed
in both groups during follow-up. Cox models will be used to estimate adjusted hazard ratios.
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