Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Fish oil; Placebo
Intervention description: Fish oil supplements 4 gms will be taken daily for 24 weeks.; Placebo supplements will be taken daily for 24 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Fish Oil

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.
    

Eligibility 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