Studies of the Prevention of Atrial Fibrillation by ALA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410839
Recruitment Status : Unknown
Verified August 2004 by University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2006
Last Update Posted : December 13, 2006
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University of Toronto

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diet Therapy Procedure: ALA rich diet Phase 2

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 Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study
Study Start Date : June 1999
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. rate of recurrence and length of time to first recurrence of atrial fibrillation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410839

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
Principal Investigator: Serge Renaud, MD, PhD Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France

Publications: Identifier: NCT00410839     History of Changes
Other Study ID Numbers: 99-04 (CPPRB Bordeaux B)
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: December 13, 2006
Last Verified: August 2004

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes