Studies of the Prevention of Atrial Fibrillation by ALA

NCT ID: NCT00410839

Last Updated: 2006-12-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2003-06-30

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.

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. Setting: Three university hospital centers in the Bordeaux region, France. Patients: 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol.

Intervention: A canola margarine and oil together with a Mediterranean diet (ALA ω-3, 1.4 g/d) 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.

Conditions

Atrial Fibrillation; Diet Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

ALA rich diet

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients hospitalized in one of the three centers in the Bordeaux region, and who subsequently underwent successful electrocardioversion for atrial fibrillation.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Serge Renaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France

Locations

Emile Roux Hospital

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 7911176 (View on PubMed)

Other Identifiers

99-04 (CPPRB Bordeaux B)

Identifier Type: -

Identifier Source: org_study_id