Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Fish Oil for Atrial Fibrillation - Effect and Mechanisms|
- Documented Recurrence of Atrial Fibrillation/Atrial Flutter [ Time Frame: Measured at Week 24 or exit ] [ Designated as safety issue: No ]Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.
|Study Start Date:||November 2007|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Fish Oil
4 grams fish oil daily for 24 weeks
Drug: Fish oil
Fish oil supplements 4 gms will be taken daily for 24 weeks.
Other Name: Lovaza capsule (1 gm)containing 465 mg EPA and 375 mg DHA.
Placebo Comparator: Placebo
corn oil taken daily for 24 weeks
Placebo supplements will be taken daily for 24 weeks.
Other Name: Corn oil
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552084
|United States, Tennessee|
|Vanderbilt Medical School|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Charles M. Stein||Vanderbilt Medical School|