Status:
COMPLETED
Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
University Hospital, Bordeaux
Conditions:
Atrial Fibrillation
Diet Therapy
Eligibility:
All Genders
18-77 years
Phase:
PHASE2
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, the...
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. ...
Eligibility Criteria
Inclusion
- patients hospitalized in one of the three centers in the Bordeaux region
- clinical diagnosis of atrial fibrillation
- who subsequently underwent successful electrical cardioversion
Exclusion
- unable to receive electrical cardioversion
- already enrolled in another trial
- unable or unwilling to comply with the diet recommendations (experimental or control) or follow-up requirements
- clinically significant cardiac disease, advanced heart failure, cardiac cachexia
- thyroid disease, treated or untreated,
- clinically significant hepatic or renal disease
- history of malignant disease
- alcohol abuse
- 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
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00410020
Start Date
June 1 1999
End Date
June 1 2003
Last Update
December 12 2006
Active Locations (3)
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1
Girac Hospital
Angoulême, France, 16470
2
Hôpital du Haut-Lévêque
Bordeaux, France, 33604
3
Robert Boulin Hospital
Libourne, France, 33500