Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

NCT00410020 | Completed Phase 2

• 2 other identifiers: DGS 99032199-04 (CPPRB BORDEAUX B)
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation; Diet Therapy

Keywords

alpha linolenic acid; atrial fibrillation; omega 3 fatty acids; diet; rapeseed oil; canola oil; cardiovascular diseases

Outcome Measures

Primary Outcomes (2)

• Rate of recurrence on periods

• Length of time to first recurrence of atrial fibrillation

Secondary Outcomes (2)

• subgroup analysis (high blood pressure, non persistent atrial fibrillation)

• comparison between late and early recurrence (before or after 14 days)

Interventions

Alpha-linolenic enriched diet BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients hospitalized in one of the three centers in the Bordeaux region
• clinical diagnosis of atrial fibrillation
• who subsequently underwent successful electrical cardioversion

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University Hospital, Bordeaux: collaborator

Study Sites (3)

Girac Hospital

Angoulême, 16470, France

Location

Hôpital du Haut-Lévêque

Bordeaux, 33604, France

Location

Robert Boulin Hospital

Libourne, 33500, France

Location

Related 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. doi: 10.1016/s0140-6736(94)92580-1.

  PMID: 7911176 BACKGROUND

• 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. doi: 10.1093/ajcn/61.6.1360S.

  PMID: 7754988 BACKGROUND

• Renaud S, Nordoy A. "Small is beautiful": alpha-linolenic acid and eicosapentaenoic acid in man. Lancet. 1983 May 21;1(8334):1169. doi: 10.1016/s0140-6736(83)92902-1. No abstract available.

  PMID: 6133188 BACKGROUND

• 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. doi: 10.1093/ajcn/76.6.1456. No abstract available.

  PMID: 12450919 BACKGROUND

• Renaud SC, Lanzmann-Petithory D. alpha-linolenic acid in the prevention of cardiovascular diseases. World Rev Nutr Diet. 2001;88:79-85. doi: 10.1159/000059769. No abstract available.

  PMID: 11935975 BACKGROUND

• 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. doi: 10.1093/ajcn/76.4.903. No abstract available.

  PMID: 12324307 BACKGROUND

• 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. doi: 10.1016/S0140-6736(02)11472-3.

  PMID: 12433513 BACKGROUND

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

  PMID: 11458289 BACKGROUND

• 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. doi: 10.1016/0014-2999(95)00701-6.

  PMID: 8851173 BACKGROUND

• 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. doi: 10.1093/jn/125.4.1003.

  PMID: 7722678 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Paul Broustet, MD, PhD

  Universitary Hospital Haut-Lévêque Bordeaux France

  PRINCIPAL INVESTIGATOR

• Serge C Renaud, VMD, PhD

  Bordeaux2 University

  STUDY CHAIR

• Dominique Lanzmann-Petithory, MD, PhD

  Bordeaux2 University - Paris AP Hospitals

  STUDY DIRECTOR

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 11, 2006
• First Posted: December 12, 2006
• Study Start: June 1, 1999
• Study Completion: June 1, 2003
• Last Updated: December 12, 2006

Record last verified: 2006-12

Locations

FR (3)