Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00410020

Collaborator

University Hospital, Bordeaux (Other)

130

Enrollment

Locations

Duration (Months)

43.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Diet Therapy	Behavioral: Alpha-linolenic enriched diet	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 1999

Study Completion Date :

Jun 1, 2003

Outcome Measures

Primary Outcome Measures

Rate of recurrence on periods []
Length of time to first recurrence of atrial fibrillation []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Girac Hospital	Angouleme	France	16470
2	Hôpital du Haut-Lévêque	Bordeaux	France	33604
3	Robert Boulin Hospital	Libourne	France	33500

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
University Hospital, Bordeaux

Investigators

Principal Investigator: Jean-Paul Broustet, MD, PhD, Universitary Hospital Haut-Lévêque Bordeaux France
Study Chair: Serge C Renaud, VMD, PhD, Bordeaux2 University
Study Director: Dominique Lanzmann-Petithory, MD, PhD, Bordeaux2 University - Paris AP Hospitals