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Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Bordeaux
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00410020
First received: December 11, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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 2

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:

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:

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 May 23, 2013