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Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed
Phase 2

Conditions

Atrial Fibrillation
Diet Therapy

Treatments

Behavioral: Alpha-linolenic enriched diet

Study type

Interventional

Funder types

Other

Identifiers

NCT00410020
DGS 990321
99-04 (CPPRB BORDEAUX B)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 77 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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