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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborators: eCardio Diagnostics; GlaxoSmithKline; National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• >=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

Exclusion Criteria:

• 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