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N-3 fatty acid supplementation on arrhythmia recurrence in atrial fibrillation

Randomised trial of the effect of long-chain n-3 polyunsaturated fatty acids on arrhythmia recurrence in atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52203885
Enrollment
332
Registered
2008-06-30
Start date
2008-09-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Cardiovascular disease/cardiac arrhythmias Circulatory System Atrial fibrillation and flutter

Interventions

Experimental: N-3 polyunsaturated fatty acids (fish oil) given daily as 2.4 g eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) daily over a minimum treatment period of 6 months (two capsule

Sponsors

Montreal Heart Institute (Institut de cardiologie de Montréal) (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged greater than or equal to 18 years, either sex 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 greater than 10 minutes within the past 6 months 5. Electrocardiogram (ECG) documentation of AF 6. Left ventricular (LV) ejection fraction greater than 40% 7. Normal thyroid stimulating hormone (TSH)

Exclusion criteria

Exclusion criteria: 1. Chronic AF (continuously present for greater than 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 (New York Heart Association Functional Class [NHYA FC] III - IV) 5. Left ventricular dysfunction (ejection fraction [EF] less than 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, anaemia) 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

Design outcomes

Primary

MeasureTime frame
Time to first relapse of atrial fibrillation measured from 0 to 6 months minimum, up to 16 months if no AF recurrence between 6 - 16 months.

Secondary

MeasureTime frame
1. High-sensitivity C-reactive protein levels measured at 0 and 6 months 2. Serum myeloperoxidase levels measured at 0 and 6 months

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026