Mediterranean Diet Plus Extravirgin Olive Oil in the Prevention of Recurrent Arrhythmias. The PREDIMAR (PREvención Con DIeta Mediterránea de Arritmias Recurrentes) Trial

Atrial Fibrillation Clinical Trial

— PREDIMAR  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03053843
• Other study ID #: MeDiet+EVOO after AF ablation
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2020
• Source: Fundación de investigación HM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 720
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with symptomatic paroxysmal AF (with evidence of more than one symptomatic episode in the last year and at least one documented episode) upon whom catheter ablation is performed.

• Patients with persistent symptomatic AF upon whom catheter ablation is performed.

Exclusion Criteria:

• Serious medical condition that prevents dietary intervention (gastrointestinal disease with intolerance to fats, advanced malignancy, neurological, psychiatric or severe endocrine disease)

• Any other pathology or medical condition that limits survival to less than one year; Immunodeficiency or HIV-positive,

• Consumption of illegal drugs,

• Chronic alcoholism or total consumption of alcohol >80 g/d

• Body mass index > 40 kg/m 2,

• Difficulty or major inconvenience with changing dietary habits, inability to follow a style of Mediterranean diet, low probability of changing dietary habits according to the models of Prochaska and Diciemente (Nigg, 1999)

• History of food allergy or hypersensitivity to any component of EVOO

• Participation in a clinical trial carried out with drugs or use of a drug in experimental state during the year prior to inclusion

• Institutionalized patients for chronic treatment, with lack of autonomy and with inability to perform the clinical follow-up,

• Impossibility of telephone contact

• Patients with acute infection or inflammatory process (e.g. pneumonia) may be included in the study three months after the resolution of the infectious symptoms.

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Spain	Teresa Barrio Lopez	Madrid
Spain	Teresa Barrio López	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Fundación de investigación HM	Hospital General Universitario de Alicante, University Hospital Virgen de las Nieves, University of Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González MA; PREDIMED Study Investigators — View Citation

Martínez-González MÁ, Toledo E, Arós F, Fiol M, Corella D, Salas-Salvadó J, Ros E, Covas MI, Fernández-Crehuet J, Lapetra J, Muñoz MA, Fitó M, Serra-Majem L, Pintó X, Lamuela-Raventós RM, Sorlí JV, Babio N, Buil-Cosiales P, Ruiz-Gutierrez V, Estruch R, Al — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial tachyarrhythmias documented by electrocardiogram or recorder device	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.	mean follow up of 2 years
Secondary	Atrial fibrillation documented by electrocardiogram or recorder device	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.	mean follow up of 2 years
Secondary	changes in Inflammatory markers in blood samples	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.	1 year follow up
Secondary	Changes in quality of life measured by SF-36 questionnaire	Change in quality of life during the follow up measured by SF-36 questionnaire	mean follow up of 2 years