Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet
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|ClinicalTrials.gov Identifier: NCT00410020|
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : December 12, 2006
An alpha linolenic acid (ALA) rich diet in the Lyon Diet 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, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.
We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Diet Therapy||Behavioral: Alpha-linolenic enriched diet||Phase 2|
Objective: To determine 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 patients randomized immediately after successful atrial fibrillation electrical cardioversion.
Intervention: A canola margarine and oil, 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)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study|
|Study Start Date :||June 1999|
|Estimated Study Completion Date :||June 2003|
- Rate of recurrence on periods
- Length of time to first recurrence of atrial fibrillation
- subgroup analysis (high blood pressure, non persistent atrial fibrillation)
- comparison between late and early recurrence (before or after 14 days)
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 ClinicalTrials.gov identifier (NCT number): NCT00410020
|Angouleme, France, 16470|
|Hôpital du Haut-Lévêque|
|Bordeaux, France, 33604|
|Robert Boulin Hospital|
|Libourne, France, 33500|
|Principal Investigator:||Jean-Paul Broustet, MD, PhD||Universitary Hospital Haut-Lévêque Bordeaux France|
|Study Chair:||Serge C Renaud, VMD, PhD||Bordeaux2 University|
|Study Director:||Dominique Lanzmann-Petithory, MD, PhD||Bordeaux2 University - Paris AP Hospitals|