Studies of the Prevention of Atrial Fibrillation by ALA

Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Diet Therapy
• Intervention / Treatment: Procedure: ALA rich diet

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.

• Study Type: Interventional
• Enrollment: 130
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 94456
    • Emile Roux Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
rate of recurrence and length of time to first recurrence of atrial fibrillation.

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University Hospital, Bordeaux
• Investigators: Principal Investigator: Serge Renaud, MD, PhD, Emile Roux Hospital, A.P.H. Paris, 94456 Limeil-Brevannes, France

Publications and helpful links

General Publications

• 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. Erratum In: Lancet 1995 Mar 18;345(8951):738.

Study record dates

Study Major Dates

• Study Start: June 1, 1999
• Primary Completion: December 7, 2022
• Study Completion: June 1, 2003

Study Registration Dates

• First Submitted: December 12, 2006
• First Submitted That Met QC Criteria: December 12, 2006
• First Posted (Estimate): December 13, 2006

Study Record Updates

• Last Update Posted (Estimate): December 13, 2006
• Last Update Submitted That Met QC Criteria: December 12, 2006
• Last Verified: August 1, 2004

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 99-04 (CPPRB BORDEAUX B)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No