Viewing Study NCT00410020



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00410020
Status: COMPLETED
Last Update Posted: 2006-12-12
First Post: 2006-12-11

Brief Title: Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet a Randomized Study
Status: COMPLETED
Status Verified Date: 2006-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
99-04 CPPRB BORDEAUX B None None None