Mediterranean Diet Plus Extravirgin Olive Oil in the Prevention of Recurrent Arrhythmias. The PREDIMAR (PREvención Con DIeta Mediterránea de Arritmias Recurrentes) Trial (PREDIMAR)
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|ClinicalTrials.gov Identifier: NCT03053843|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2017
Last Update Posted : April 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Atrial Arrhythmia||Dietary Supplement: Mediterranean diet plus extra virgin olive oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||March 22, 2017|
|Actual Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2022|
Experimental: Mediterranean diet plus extra virgin olive oil
These patients will receive 1 liter of EVOO per week free of charge and dietary advice on how to follow a Mediterranean diet with contacts every two months.
Dietary Supplement: Mediterranean diet plus extra virgin olive oil
The patients in the intervention group will receive 1 liter of EVOO per week free of charge and dietary advice on how to follow a Mediterranean diet with contacts every two months. Dietary intervention will be carried out by nutritionists with previous experience in the PREDIMED study. All of them were registered, trained and certified for developing the PREDIMED intervention protocol that is similar to the one to be carried out in this study. The theoretical sessions with patients about dietary education shall be conducted in telephone form, using the internet and sending comprehensive written material to their homes that includes recipes, shopping lists, menus and explanations of typical food in the Mediterranean diet
No Intervention: no specific diet
The control group will be assigned to the usual care and patients assigned to this group will not receive any special intervention to follow a particular diet, as occurs in the current clinical practice.
- atrial tachyarrhythmias documented by electrocardiogram or recorder device [ Time Frame: mean follow up of 2 years ]Atrial tachyarrhythmia is defined at any fast rate (>100 bpm) of supraventricular origin lasting more than 30 seconds and that is documented by ECG, Holter or event monitor.
- Atrial fibrillation documented by electrocardiogram or recorder device [ Time Frame: mean follow up of 2 years ]AF is defined at any irregular atrial rhythm lasting more than 30 seconds and that is documented by ECG, Holter or event monitor. AF may or may not be symptomatic.
- changes in Inflammatory markers in blood samples [ Time Frame: 1 year follow up ]Prior to ablation blood samples will be collected for determination of inflammatory parameters in a subsample of the study (neutrophil to lymphocyte ratio, TNF-alpha, fibrinogen, IL-2, IL6, IL-8, C-reactive protein). At 3 and 12 months of follow-up the determination of these parameters will be repeated.
- Changes in quality of life measured by SF-36 questionnaire [ Time Frame: mean follow up of 2 years ]Change in quality of life during the follow up measured by SF-36 questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053843
|Teresa Barrio Lopez|
|Madrid, Spain, 28033|
|Teresa Barrio López|
|Madrid, Spain, 28033|
|Study Chair:||Miguel A Martinez González, MD, PhD, MPH||University of Navarra|
|Study Director:||Jesus Almendral Garrote, MD, PhD, FESC||Fundación HM|
|Principal Investigator:||Teresa Barrio Lopez, MD, PhD||Fundación HM|