Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

Atrial Fibrillation Clinical Trial

Official title:

Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410020
• Other study ID #: DGS 990321
• Secondary ID: 99-04 (CPPRB BOR
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2006
• Last updated: December 11, 2006
• Start date: June 1999
• Est. completion date: June 2003

Study information

• Verified date: December 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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, there has been a growing interest in ALA, ω-3 fatty acid family precursor, as a cardioprotective nutrient. Much of the interest has focused on the potential antiarrhythmic effect of longer chain ω-3 fatty acids, DHA and EPA, derived from fish.

We therefore concluded it important to test wether vegetable source ω-3 also had antiarrhythmic effects, as shown in animals by Leaf and McLennan, since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Diet Heart Study.

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.

Setting: Three university hospital centers in the Bordeaux region, France.

Patients: 98 patients randomized immediately after successful atrial fibrillation electrical cardioversion.

Intervention: A canola margarine and oil, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

Inclusion Criteria:

• patients hospitalized in one of the three centers in the Bordeaux region

• clinical diagnosis of atrial fibrillation

• who subsequently underwent successful electrical cardioversion

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diet Therapy

Intervention

Behavioral:
• Alpha-linolenic enriched diet

Locations

Country	Name	City	State
France	Girac Hospital	Angouleme
France	Hôpital du Haut-Lévêque	Bordeaux
France	Robert Boulin Hospital	Libourne

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (10)

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. Erratum in: Lancet 1995 Mar 18;345(8951):738. — View Citation

Kang JX, Leaf A. Protective effects of free polyunsaturated fatty acids on arrhythmias induced by lysophosphatidylcholine or palmitoylcarnitine in neonatal rat cardiac myocytes. Eur J Pharmacol. 1996 Feb 15;297(1-2):97-106. — View Citation

Lanzmann-Petithory D, Pueyo S, Renaud S. Primary prevention of cardiovascular diseases by alpha-linolenic acid. Am J Clin Nutr. 2002 Dec;76(6):1456; author reply 1456-7. — View Citation

Lanzmann-Petithory D. Alpha-linolenic acid and cardiovascular diseases. J Nutr Health Aging. 2001;5(3):179-83. Review. — View Citation

McLennan PL, Dallimore JA. Dietary canola oil modifies myocardial fatty acids and inhibits cardiac arrhythmias in rats. J Nutr. 1995 Apr;125(4):1003-9. — View Citation

Renaud S, de Lorgeril M, Delaye J, Guidollet J, Jacquard F, Mamelle N, Martin JL, Monjaud I, Salen P, Toubol P. Cretan Mediterranean diet for prevention of coronary heart disease. Am J Clin Nutr. 1995 Jun;61(6 Suppl):1360S-1367S. — View Citation

Renaud S, Nordøy A. "Small is beautiful": alpha-linolenic acid and eicosapentaenoic acid in man. Lancet. 1983 May 21;1(8334):1169. — View Citation

Renaud SC, Lanzmann-Petithory D. alpha-linolenic acid in the prevention of cardiovascular diseases. World Rev Nutr Diet. 2001;88:79-85. Review. — View Citation

Renaud SC, Lanzmann-Petithory D. The beneficial effect of alpha-linolenic acid in coronary artery disease is not questionable. Am J Clin Nutr. 2002 Oct;76(4):903-4; author reply 904-6. — View Citation

Singh RB, Dubnov G, Niaz MA, Ghosh S, Singh R, Rastogi SS, Manor O, Pella D, Berry EM. Effect of an Indo-Mediterranean diet on progression of coronary artery disease in high risk patients (Indo-Mediterranean Diet Heart Study): a randomised single-blind trial. Lancet. 2002 Nov 9;360(9344):1455-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recurrence on periods
Primary	Length of time to first recurrence of atrial fibrillation
Secondary	subgroup analysis (high blood pressure, non persistent atrial fibrillation)
Secondary	comparison between late and early recurrence (before or after 14 days)