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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
Sponsor:
Collaborators:
University of Navarra
University Hospital Virgen de las Nieves
Hospital General Universitario de Alicante
Information provided by (Responsible Party):
Teresa Barrio, Fundación de investigación HM

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Arrhythmia Dietary Supplement: Mediterranean diet plus extra virgin olive oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Spain
Teresa Barrio Lopez
Madrid, Spain, 28033
Teresa Barrio López
Madrid, Spain, 28033
Sponsors and Collaborators
Fundación de investigación HM
University of Navarra
University Hospital Virgen de las Nieves
Hospital General Universitario de Alicante
Investigators
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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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Teresa Barrio, MD, PhD, Fundación de investigación HM
ClinicalTrials.gov Identifier: NCT03053843    
Other Study ID Numbers: MeDiet+EVOO after AF ablation
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa Barrio, Fundación de investigación HM:
Atrial fibrillation
Mediterranean Diet
Extra Virgin Olive Oil
Ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes