Studies of the Prevention of Atrial Fibrillation by ALA

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2004 by University of Toronto. Recruitment status was Active, not recruiting

First Received on December 12, 2006. No Changes Posted

Sponsor:	University of Toronto
Collaborators:	University Hospital, Bordeaux Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	University of Toronto
ClinicalTrials.gov Identifier:	NCT00410839

Purpose

An alpha-linolenic acid (ALA) rich diet in the Lyon 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 as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids, especially the longer chain ω-3 fatty acids, DHA and EPA, derived from fish. We therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic effects, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Heart Study.

Condition	Intervention	Phase
Atrial Fibrillation Diet Therapy	Procedure: ALA rich diet	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:

rate of recurrence and length of time to first recurrence of atrial fibrillation.

Estimated Enrollment:	130
Study Start Date:	June 1999
Estimated Study Completion Date:	June 2003

Detailed Description:

Objective: We determined 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 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol.

Intervention: A canola margarine and oil together with a Mediterranean diet (ALA ω-3, 1.4 g/d) 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.

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.

Exclusion Criteria:

included patients who were unable to receive electrocardioversion or those who were already enrolled in another trial
patients who were unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
patients with clinically significant cardiac disease, advanced heart failure, cardiac cachexia, thyroid disease, treated or untreated, clinically significant hepatic or renal disease or a history of malignant disease or alcohol abuse were not included
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410839

Locations

France
Emile Roux Hospital
Paris, France, 94456

Sponsors and Collaborators

University of Toronto

University Hospital, Bordeaux

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator:

Serge Renaud, MD, PhD

Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France

More Information

Publications:

de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9. Erratum in: Lancet 1995 Mar 18;345(8951):738.

ClinicalTrials.gov Identifier:	NCT00410839 History of Changes
Other Study ID Numbers:	99-04 (CPPRB Bordeaux B)
Study First Received:	December 12, 2006
Last Updated:	December 12, 2006
Health Authority:	France: Direction Generale de la Sante, Ministere de la sante

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012