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Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

Primary Purpose

Atrial Fibrillation, Diet Therapy

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Alpha-linolenic enriched diet

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring alpha linolenic acid, atrial fibrillation, omega 3 fatty acids, diet, rapeseed oil, canola oil, cardiovascular diseases

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Girac Hospital
Hôpital du Haut-Lévêque
Robert Boulin Hospital

Outcomes

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)

Full Information

NCT ID

NCT00410020

First Posted

December 11, 2006

Last Updated

December 11, 2006

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT00410020

Brief Title

Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2006

Overall Recruitment Status

Completed

Study Start Date

June 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

University Hospital, Bordeaux

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Diet Therapy

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Alpha-linolenic enriched diet

Primary Outcome Measure Information:

Title

Rate of recurrence on periods

Title

Length of time to first recurrence of atrial fibrillation

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

77 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Paul Broustet, MD, PhD

Organizational Affiliation

Universitary Hospital Haut-Lévêque Bordeaux France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Serge C Renaud, VMD, PhD

Organizational Affiliation

Bordeaux2 University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dominique Lanzmann-Petithory, MD, PhD

Organizational Affiliation

Bordeaux2 University - Paris AP Hospitals

Official's Role

Study Director

Facility Information:

Facility Name

Girac Hospital

City

Angouleme

ZIP/Postal Code

16470

Country

France

Facility Name

Hôpital du Haut-Lévêque

City

Bordeaux

ZIP/Postal Code

33604

Country

France

Facility Name

Robert Boulin Hospital

City

Libourne

ZIP/Postal Code

33500

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

7911176

Citation

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.

Results Reference

background

PubMed Identifier

7754988

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. doi: 10.1093/ajcn/61.6.1360S.

Results Reference

background

PubMed Identifier

6133188

Citation

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.

Results Reference

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PubMed Identifier

12450919

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

Results Reference

background

PubMed Identifier

11935975

Citation

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.

Results Reference

background

PubMed Identifier

12324307

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

Results Reference

background

PubMed Identifier

12433513

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

Results Reference

background

PubMed Identifier

11458289

Citation

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

Results Reference

background

PubMed Identifier

8851173

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

Results Reference

background

PubMed Identifier

7722678

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. doi: 10.1093/jn/125.4.1003.

Results Reference

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Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

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