Status:
COMPLETED
Multi_center Study to Evaluate the Effect of N-3 Fatty Acids (OMEGA-3) on Arrhythmia Recurrence in Atrial Fibrillation
Lead Sponsor:
Montreal Heart Institute
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT01235130
Start Date
March 1 2009
End Date
May 1 2013
Last Update
March 17 2022
Active Locations (1)
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1
Montreal Heart Institute Coordinating Center
Montreal, Quebec, Canada, H1Y 3N1