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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
eCardio, Houston TX
GlaxoSmithKline
Information provided by (Responsible Party):
C. Michael Stein, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00552084
First received: October 31, 2007
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Fish oil
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Recurrence of AF/AFL, recurrence of symptomatic AF/AFL, inflammatory markers [ Time Frame: Measured at Week 24 or exit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: November 2007
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
Placebo supplements will be taken daily for 24 weeks.
Other Name: Corn oil

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 thearpy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552084

Locations
United States, Tennessee
Vanderbilt Medical School
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
eCardio, Houston TX
GlaxoSmithKline
Investigators
Principal Investigator: Charles M. Stein Vanderbilt Medical School
  More Information

No publications provided

Responsible Party: C. Michael Stein, Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00552084     History of Changes
Other Study ID Numbers: 543, R01HL087254, HL 087254
Study First Received: October 31, 2007
Last Updated: June 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Fish Oil

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014