Studies of the Prevention of Atrial Fibrillation by ALA
Recruitment status was Active, not recruiting
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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 2 |
| 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 |
- 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 |
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 |
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| France | |
| Emile Roux Hospital | |
| Paris, France, 94456 | |
| Principal Investigator: | Serge Renaud, MD, PhD | Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France |
More Information
Publications:
| 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 May 16, 2013