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Sponsors and Collaborators: |
University of Toronto University Hospital, Bordeaux Institut National de la Santé Et de la Recherche Médicale, France |
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Information provided by: | University of Toronto |
ClinicalTrials.gov Identifier: | NCT00410839 |
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 |
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Atrial Fibrillation Diet Therapy |
Procedure: ALA rich diet |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study |
Estimated Enrollment: | 130 |
Study Start Date: | June 1999 |
Estimated Study Completion Date: | June 2003 |
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.
Ages Eligible for Study: | 18 Years to 77 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Emile Roux Hospital | |
Paris, France, 94456 |
Principal Investigator: | Serge Renaud, MD, PhD | Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France |
Study ID Numbers: | 99-04 (CPPRB Bordeaux B) |
Study First Received: | December 12, 2006 |
Last Updated: | December 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00410839 History of Changes |
Health Authority: | France: Direction Generale de la Sante, Ministere de la sante |
Heart Diseases Atrial Fibrillation Recurrence Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |