Studies of the Prevention of Atrial Fibrillation by ALA
Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study
1 other identifier
interventional
130
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 atrial-fibrillation
Started Jun 1999
Longer than P75 for phase_2 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 12, 2006
CompletedFirst Posted
Study publicly available on registry
December 13, 2006
CompletedDecember 13, 2006
August 1, 2004
December 12, 2006
December 12, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
rate of recurrence and length of time to first recurrence of atrial fibrillation.
Interventions
Eligibility Criteria
You may qualify if:
- patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emile Roux Hospital
Paris, 94456, France
Related Publications (1)
de Lorgeril M, Renaud S, Mamelle N, Salen P, Martin JL, Monjaud I, Guidollet J, Touboul P, Delaye J. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9. doi: 10.1016/s0140-6736(94)92580-1.
PMID: 7911176BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Serge Renaud, MD, PhD
Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 12, 2006
First Posted
December 13, 2006
Study Start
June 1, 1999
Study Completion
June 1, 2003
Last Updated
December 13, 2006
Record last verified: 2004-08