Studies of the Prevention of Atrial Fibrillation by ALA
This trial is active, not recruiting.
|Conditions||atrial fibrillation, diet therapy|
|Treatment||ala rich diet|
|Sponsor||University of Toronto|
|Collaborator||University Hospital, Bordeaux|
|Start date||June 1999|
|End date||June 2003|
|Trial size||130 participants|
|Trial identifier||NCT00410839, 99-04 (CPPRB Bordeaux B)|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
rate of recurrence and length of time to first recurrence of atrial fibrillation.
Male or female participants from 18 years up to 77 years old.
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.
|Official title||Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study|
|Principal investigator||Serge Renaud, MD, PhD|
|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.|
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