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Arrhythmia Prevention With an Alpha-Linolenic Enriched Diet

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00410020
Enrollment
130
Registered
2006-12-12
Start date
1999-06-30
Completion date
2003-06-30
Last updated
2006-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Diet Therapy

Keywords

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

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.

Interventions

BEHAVIORALAlpha-linolenic enriched diet

Sponsors

University Hospital, Bordeaux
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026