Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	University Hospital, Bordeaux
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00410020

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation Diet Therapy	Behavioral: Alpha-linolenic enriched diet	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Secondary Prevention of Atrial Fibrillation With an Alpha-Linolenic Enriched Diet : a Randomized Study

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Rate of recurrence on periods
Length of time to first recurrence of atrial fibrillation

Secondary Outcome Measures:

subgroup analysis (high blood pressure, non persistent atrial fibrillation)
comparison between late and early recurrence (before or after 14 days)

Estimated Enrollment:	130
Study Start Date:	June 1999
Estimated Study Completion Date:	June 2003

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410020

Locations

France
Girac Hospital
Angouleme, France, 16470
Hôpital du Haut-Lévêque
Bordeaux, France, 33604
Robert Boulin Hospital
Libourne, France, 33500

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

University Hospital, Bordeaux

Investigators

Principal Investigator:	Jean-Paul Broustet, MD, PhD	Universitary Hospital Haut-Lévêque Bordeaux France
Study Chair:	Serge C Renaud, VMD, PhD	Bordeaux2 University
Study Director:	Dominique Lanzmann-Petithory, MD, PhD	Bordeaux2 University - Paris AP Hospitals

More Information

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

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.

Renaud S, Nordoy A. "Small is beautiful": alpha-linolenic acid and eicosapentaenoic acid in man. Lancet. 1983 May 21;1(8334):1169. No abstract available.

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. No abstract available.

Renaud SC, Lanzmann-Petithory D. alpha-linolenic acid in the prevention of cardiovascular diseases. World Rev Nutr Diet. 2001;88:79-85. Review. No abstract available.

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. No abstract available.

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.

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

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.

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.

ClinicalTrials.gov Identifier:	NCT00410020 History of Changes
Other Study ID Numbers:	DGS 990321, 99-04 (CPPRB BORDEAUX B)
Study First Received:	December 11, 2006
Last Updated:	December 11, 2006
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

alpha linolenic acid
atrial fibrillation
omega 3 fatty acids
diet

rapeseed oil
canola oil
cardiovascular diseases

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012