Status:
UNKNOWN
Studies of the Prevention of Atrial Fibrillation by ALA
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
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 Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation (Lancet 1994). Since then, there has...
Detailed 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. ...
Eligibility Criteria
Inclusion
- patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.
Exclusion
- 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.
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
NCT00410839
Start Date
June 1 1999
End Date
June 1 2003
Last Update
December 13 2006
Active Locations (1)
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1
Emile Roux Hospital
Paris, France, 94456