Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation (AFFORD)

University of Montreal

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Drug: Placebo soybean oil

Drug: OMEGA-3

Study type

Interventional

Funder types

Other

Identifiers

NCT01235130

MCT88068 (Other Grant/Funding Number)

Details and patient eligibility

About

The general objective of this study is to demonstrate the effectiveness of n-3 fatty acids, 2.4 grams per day, to prevent recurrence of atrial fibrillation in patients with paroxysmal or persistent AF in whom a rhythm-control strategy is planned.

Full description

Atrial fibrillation (AF) represents the most common arrhythmia of clinical importance. The prevalence of AF in the general population has been estimated to be just below 1%, or 300,000 Canadians, and rising. Current strategies in AF to preserve normal sinus rhythm include pharmacological therapy with agents that demonstrate intermediate efficacy and significant adverse effects. Newer non-pharmacological strategies such as pulmonary vein ablation are suitable for only a minority of patients and are an expensive method of treatment. As a result, simple, safe, inexpensive and effective strategies to treat AF and preserve sinus rhythm are required given the great health and financial burden that this condition represents to our society.

Omega-3 or "n-3" polyunsaturated fatty acids (n-3 fatty acids) represent a novel approach to the prevention and treatment of AF. N-3 fatty acids have known anti-arrhythmic properties and are associated with a lower risk of sudden (arrhythmic) death. Additionally, n-3 fatty acids have significant anti-inflammatory properties and potential anti-oxidant effects. Higher consumption of non-fried fish was recently shown to confer a lower incidence of new onset AF in elderly adults. N-3 fatty acids might therefore represent a useful strategy for maintenance of sinus rhythm in patients with AF, given their potential to act on several mechanisms simultaneously. We seek to test this hypothesis in the current clinical trial proposal.

Enrollment

337 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years
Written informed consent
Non-valvular paroxysmal or persistent AF in whom a rhythm control strategy is planned
Duration of at least one symptomatic AF episode > 10 minutes within the past 6 months
ECG documentation of AF

Exclusion criteria

Chronic AF (continuously present for > 3 months)
Myocardial infarction within the past month prior to selection visit
Cardiac or thoracic surgery within the past 3 months or likely to be performed during trial
Moderate to severe congestive heart failure (NHYA FC III-IV)
Known left ventricular dysfunction (EF< 40%).
Mitral stenosis
Moderate to severe mitral insufficiency (Grade 3-4/4)
AF secondary to an acute reversible condition (untreated or uncontrolled hyperthyroidism, post- operative AF, fever, anemia)
Need for anti-arrhythmic therapy for a condition other than atrial fibrillation
Wolff-Parkinson-White syndrome
Any medical condition making compliance with study treatment unlikely
Current use of n-3 fatty acid supplements or use within the past 3 months
Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (Patients must have adequate contraception as determined by the investigator),
Participation in another study at the same time or within 30 days of randomization.
Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
Suspected or known allergy to any ingredients in the study product or placebo, fish or shellfish .