Clinical trial NCT03053843: Mediterranean Diet Plus Extravirgin Olive Oil in the Prevention of Recurrent Arrhythmias. The PREDIMAR (PREvención Con DIeta Mediterránea de Arritmias Recurrentes) 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Atrial Arrhythmia
Keywords: Atrial fibrillation
Mediterranean Diet
Extra Virgin Olive Oil
Ablation
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
Collaborators: name: University of Navarra
name: University Hospital Virgen de las Nieves
name: Hospital General Universitario de Alicante
First posted: 2017-02-15
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: atrial tachyarrhythmias documented by electrocardiogram or recorder device
timeFrame: mean follow up of 2 years
Secondary outcomes:
measure: Atrial fibrillation documented by electrocardiogram or recorder device
timeFrame: mean follow up of 2 years
measure: changes in Inflammatory markers in blood samples
timeFrame: 1 year follow up
measure: Changes in quality of life measured by SF-36 questionnaire
timeFrame: mean follow up of 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Teresa Barrio Lopez
city: Madrid
country: Spain
facility: Teresa Barrio López
Study officials:
affiliation: University of Navarra
name: Miguel A Martinez González, MD, PhD, MPH
role: STUDY_CHAIR
affiliation: Fundación HM
name: Jesus Almendral Garrote, MD, PhD, FESC
role: STUDY_DIRECTOR
affiliation: Fundación HM
name: Teresa Barrio Lopez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Gonzalez MA, Toledo E, Aros F, Fiol M, Corella D, Salas-Salvado J, Ros E, Covas MI, Fernandez-Crehuet J, Lapetra J, Munoz MA, Fito M, Serra-Majem L, Pinto X, Lamuela-Raventos RM, Sorli JV, Babio N, Buil-Cosiales P, Ruiz-Gutierrez V, Estruch R, Alonso A; PREDIMED Investigators. Extravirgin olive oil consumption reduces risk of atrial fibrillation: the PREDIMED (Prevencion con Dieta Mediterranea) trial. Circulation. 2014 Jul 1;130(1):18-26. doi: 10.1161/CIRCULATIONAHA.113.006921. Epub 2014 Apr 30.
citation: Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.
citation: Goni L, de la O V, Barrio-Lopez MT, Ramos P, Tercedor L, Ibanez-Criado JL, Castellanos E, Ibanez Criado A, Macias Ruiz R, Garcia-Bolao I, Almendral J, Martinez-Gonzalez MA, Ruiz-Canela M. A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial. J Med Internet Res. 2020 Dec 7;22(12):e21436. doi: 10.2196/21436.
citation: Barrio-Lopez MT, Ruiz-Canela M, Ramos P, Tercedor L, Ibanez Criado JL, Ortiz M, Goni L, Ibanez Criado A, Macias-Ruiz R, Garcia-Bolao I, Martinez-Gonzalez MA, Almendral J. PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study in patients with atrial fibrillation: Rationale, design and methods. Am Heart J. 2020 Feb;220:127-136. doi: 10.1016/j.ahj.2019.10.009. Epub 2019 Oct 26.