Studies of the Prevention of Atrial Fibrillation by ALA - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 12, 2006

Last Updated Date

December 12, 2006

Start Date ^†

June 1999

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Studies of the Prevention of Atrial Fibrillation by ALA

Official Title ^†

Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study

Brief Summary

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.

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Atrial Fibrillation
Diet Therapy

Intervention ^†

Procedure: ALA rich diet

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

130

Completion Date

June 2003

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 77 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00410839

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Toronto

Collaborators ^††

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

Information Provided By

University of Toronto

Verification Date

August 2004

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.