Studies of the Prevention of Atrial Fibrillation by ALA

Sponsor
University of Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT00410839
Collaborator
University Hospital, Bordeaux (Other), Institut National de la Santé Et de la Recherche Médicale, France (Other)
130
1
48
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Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 1999
Study Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

  1. rate of recurrence and length of time to first recurrence of atrial fibrillation. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 77 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00410839
Other Study ID Numbers:
  • 99-04 (CPPRB Bordeaux B)
First Posted:
Dec 13, 2006
Last Update Posted:
Dec 13, 2006
Last Verified:
Aug 1, 2004
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2006