Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

Study Overview
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Brief Summary
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An alpha linolenic acid (ALA) rich diet in the Lyon Diet Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since then, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.

Detailed Description
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Objective: To determine the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia. Design: Randomized parallel design efficacy study. Setting: Three university hospital centers in the Bordeaux region, France. Patients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion. Intervention: A canola margarine and oil, versus a conventional diet (control), with a one year follow-up. Main outcome measure: Length of time to first recurrence of atrial fibrillation. Significance: If ALA is antiarrhythmic, this action may explain its cardioprotective effect in clinical trials and cohort studies.

Official Title
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Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study

Conditions
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Atrial Fibrillation, Diet Therapy

Intervention / Treatment
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* Behavioral: Alpha-linolenic enriched diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients hospitalized in one of the three centers in the Bordeaux region clinical diagnosis of atrial fibrillation who subsequently underwent successful electrical cardioversion Exclusion Criteria: unable to receive electrical cardioversion already enrolled in another trial unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements clinically significant cardiac disease, advanced heart failure, cardiac cachexia thyroid disease, treated or untreated, clinically significant hepatic or renal disease history of malignant disease alcohol abuse taking ALA rich foods or recording intakes of ALA >2g/d on the control diet or reporting using <1g/d on the ALA diet was considered a major deviation from the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Alpha-linolenic enriched diet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence on periods |  |  | 
| Length of time to first recurrence of atrial fibrillation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subgroup analysis (high blood pressure, non persistent atrial fibrillation) |  |  | 
| comparison between late and early recurrence (before or after 14 days) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alpha linolenic acid, atrial fibrillation, omega 3 fatty acids, diet, rapeseed oil, canola oil, cardiovascular diseases