NCT03053843

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 9, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

February 6, 2017

Last Update Submit

April 8, 2020

Conditions

Atrial FibrillationAtrial Arrhythmia

Keywords

Atrial fibrillationMediterranean DietExtra Virgin Olive OilAblation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Atrial fibrillation documented by electrocardiogram or recorder device

    mean follow up of 2 years

  • changes in Inflammatory markers in blood samples

    1 year follow up

  • Changes in quality of life measured by SF-36 questionnaire

    mean follow up of 2 years

Study Arms (2)

Mediterranean diet plus extra virgin olive oil

EXPERIMENTAL

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

no specific diet

NO INTERVENTION

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.

Interventions

Mediterranean diet plus extra virgin olive oilDIETARY_SUPPLEMENT

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

Mediterranean diet plus extra virgin olive oil

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Teresa Barrio Lopez

Madrid, 28033, Spain

Location

Teresa Barrio López

Madrid, 28033, Spain

Location

Related Publications (4)

  • 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.

    PMID: 24787471RESULT

  • 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.

    PMID: 23432189RESULT

  • 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.

    PMID: 33284131DERIVED

  • 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.

    PMID: 31809992DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Miguel A Martinez González, MD, PhD, MPH

    University of Navarra

    STUDY CHAIR

  • Jesus Almendral Garrote, MD, PhD, FESC

    Fundación HM

    STUDY DIRECTOR

  • Teresa Barrio Lopez, MD, PhD

    Fundación HM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 15, 2017

Study Start

March 22, 2017

Primary Completion

January 31, 2020

Study Completion

January 31, 2022

Last Updated

April 9, 2020

Record last verified: 2020-04

Locations

ES(2)