Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation

Completed · Phase 4 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

Atrial fibrillation (AF) is a heart rhythm disorder that usually involves a rapid heart rate. People who take fish oil supplements may reduce the risk of a recurrence of AF. This study will evaluate the effectiveness of fish oil at decreasing the recurrence of AF and will examine the reasons why fish oil may reduce this risk.

Key facts

Study ID

NCT00552084

Run by

Vanderbilt University

People needed

190

Starts

2007-11-01

Expected to finish

2014-04-01

Last updated by the study team

2014-12-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=21 years of age
• a history of atrial fibrillation
• a history of at least two occurrences of atrial fibrillation or atrial flutter, at least one of which is atrial fibrillation
• an electrocardiogram that was recorded within 12 months of randomization showing atrial fibrillation or atrial flutter
• sinus rhythm at the time the first dose of randomized medication is taken
• stable antiarrhythmic medications
• if the patient has had an ablation for atrial fibrillation or flutter or a MAZE procedure, the qualifying episode of atrial fibrillation must have occurred at least 3 months post-procedure
• normal serum potassium level within the last 28 days
• provided informed consent

You may not qualify if…

• permanent atrial fibrillation or flutter
• New York Heart Association class III or IV heart failure or Canadian Cardiovascular Society class III or IV angina pectoris
• cardiac or thoracic surgery within the previous 3 months
• acute pericarditis within the previous 3 months
• other reversible causes of atrial fibrillation such as thyrotoxicosis
• acute myocardial infarction or unstable angina within the previous 3 months
• history of neurologic event (TIA or stroke)within the past 3 months
• history of acute congestive heart failure precipitated by atrial fibrillation, and the patient is not receiving rate-control therapy
• Wolff-Parkinson-White syndrome
• a medical condition that is likely to be fatal in less than one year
• active, uncontrolled co-morbid inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, SLE)
• receiving cytotoxic chemotherapy or radiotherapy for cancer
• taking a fish oil supplement
• allergic to fish
• bleeding event not related to trauma or surgery requiring hospitalization or transfusion in previous year
• systolic blood pressure < 90 mm Hg or heart rate <50 beats/minute
• history of ventricular fibrillation or sustained ventricular tachycardia, or presence of an implanted defibrillator placed for the occurrence of such an event or the presence of an Implantable Cardioverter-Defibrillator (ICD) that has discharged appropriately for a ventricular arrhythmia
• pregnant or breast feeding
• enrollment in another research study involving an intervention
• on dialysis or recipient of a renal transplant
• use of potentially cardiotoxic illegal drugs (cocaine, methamphetamine, opioids) in the last 12 months
• Treated for alcoholism and currently drinking alcohol to excess or alcoholic cardiomyopathy as the primary clinical diagnosis and currently drinking alcohol to excess
• presence of an iron-storage disease, such as hemochromatosis, transfusional hemosiderosis, or those subjects in whom a daily dose of up to 20 mg elemental iron (in and of itself or in addition of current iron supplementation) would post a risk for toxicity from iron overload
• subjects receiving or anticipated to receive intravenous iron therapy

Where it is running

• Vanderbilt Medical School — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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