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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 in whom a rhythm-control strategy is planned.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montreal Heart Institute

Criteria

Inclusion Criteria:

1. Age > 18 years

2. Written informed consent

3. Non-valvular paroxysmal or persistent AF in whom a rhythm control strategy is planned

4. Duration of at least one symptomatic AF episode > 10 minutes within the past 6 months

5. ECG documentation of AF

Exclusion Criteria:

1. Chronic AF (continuously present for > 3 months)

2. Myocardial infarction within the past month prior to selection visit

3. Cardiac or thoracic surgery within the past 3 months or likely to be performed during trial

4. Moderate to severe congestive heart failure (NHYA FC III-IV)

5. Known left ventricular dysfunction (EF< 40%).

6. Mitral stenosis

7. Moderate to severe mitral insufficiency (Grade 3-4/4)

8. AF secondary to an acute reversible condition (untreated or uncontrolled hyperthyroidism, post- operative AF, fever, anemia)

9. Need for anti-arrhythmic therapy for a condition other than atrial fibrillation

10. Wolff-Parkinson-White syndrome

11. Any medical condition making compliance with study treatment unlikely

12. Current use of n-3 fatty acid supplements or use within the past 3 months

13. Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (Patients must have adequate contraception as determined by the investigator),

14. Participation in another study at the same time or within 30 days of randomization.

15. Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg

16. Suspected or known allergy to any ingredients in the study product or placebo, fish or shellfish .