Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

Phase 2

Completed

• Conditions: Atrial Fibrillation; Diet Therapy

• Registration Number: NCT00410020
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 1999-06
• Study Completion: 2003-06
• Status Verified: 2006-12
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Last Update Submitted: 2006-12-11
• Study First Posted: 2006-12-12
• Last Update Posted: 2006-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of recurrence on periods
Length of time to first recurrence of atrial fibrillation

Secondary Outcome Measures

Name	Time	Method
subgroup analysis (high blood pressure, non persistent atrial fibrillation)
comparison between late and early recurrence (before or after 14 days)

Trial Locations

Locations (3)

Hôpital du Haut-Lévêque; 🇫🇷 Bordeaux, France

Girac Hospital; 🇫🇷 Angouleme, France

Robert Boulin Hospital; 🇫🇷 Libourne, France