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

Vanderbilt University

Status and phase

Completed

Phase 4

Conditions

Atrial Fibrillation

Treatments

Drug: Fish oil

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00552084

543

HL 087254

R01HL087254 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

AF is the most common type of serious heart arrhythmia. It affects approximately 2% of the population and is becoming more common. In AF, the heart's atria, or upper chambers, contract in a very disorganized and abnormal manner and are unable to correctly pump blood into the heart's ventricles, or lower chambers. Symptoms may include a rapid or irregular pulse, dizziness, fainting, or breathing difficulty. Recent studies suggest that inflammation plays a fundamental role in the development of AF. Inflammation, and the resulting oxidative stress, can cause cellular and tissue damage. In turn, this may alter heart function, potentially leading to both the onset and recurrence of AF. Markers of inflammation, such as C-reactive protein (CRP) and interleukin-6 (IL-6), are often elevated in patients with AF, providing further evidence of inflammation's role. While there are several treatment options for AF, they are usually only moderately effective. Previous research has shown that fish oil supplements have anti-inflammatory, antifibrotic, and antioxidant effects and can reduce the risk of AF following surgery. However, it is not known exactly how fish oil reduces this risk and whether the same positive effect will carry over in people who experience the more common type of AF that is unrelated to surgery. The purpose of this study is to evaluate the effectiveness of fish oil supplementation at decreasing the recurrence of AF in adults who have not undergone recent surgery. Researchers will also examine the ways in which fish oil reduces AF recurrence.

This study will enroll people who have had at least two occurrences of AF. Participants will be randomly assigned to receive either fish oil supplements or placebo for 24 weeks. At study visits at baseline and Weeks 2, 4, 8, 12, 18, and 24, participants will undergo a medical and social history review, a physical exam, and blood and urine collection. At the baseline study visit, an electrocardiogram will also occur.

Enrollment

190 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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