Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) eCardio Reliant Pharmaceuticals
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00552084

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 IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Fish Oil for Atrial Fibrillation - Effect and Mechanisms

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Recurrence of AF, recurrence of symptomatic AF, 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 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fish Oil: Experimental	Drug: Fish Oil Fish oil supplements will be taken daily for 24 weeks.
Placebo: Placebo Comparator	Drug: Placebo Placebo supplements will be taken daily for 24 weeks.

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:

Diagnosed with AF
History of at least two occurrences of AF
Electrocardiogram showing AF within 12 months of study entry
Sinus rhythm (normal beating of the heart) at study entry
Antiarrhythmic medications have been stable for at least 1 month prior to study entry
If experienced an ablation for AF, flutter, or MAZE procedure, the qualifying episode of AF must have occured at least 3 months post-procedure
Most recent serum potassium level obtained within the 28 days prior to study entry must be at a normal level

Exclusion Criteria:

Permanent AF or flutter
Canadian Cardiovascular Society Classification (CCSC) class III or IV angina pectoris
Cardiac or thoracic surgery within the 3 months prior to study entry
Acute pericarditis within the 3 months prior to study entry
Reversible cause of AF, such as active thyrotoxicosis
Acute heart attack or unstable angina within the 3 months prior to study entry
History of a focal neurologic event (e.g., transient ischemic attack, stroke, intracranial hemorrhage, bleeding into or around the brain, subarachnoid hemorrhage, subdural hematoma)within the past 3 months
Acute congestive heart failure caused by AF and the patient is not on rate control therapy
Wolff-Parkinson-White syndrome
Medical condition that is likely to be fatal within 1 after from study entry
Active uncontrolled co-morbid inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus)
Active cancer, other than skin cancer
Currently taking a fish oil supplement
Allergic to fish or fish products
Experienced a bleeding event requiring hospitalization or transfusion in the 1 year prior to study entry
Systolic blood pressure level of less than 90 mm Hg
Heart rate of less than 50 beats per minute
History of ventricular fibrillation or sustained ventricular tachycardia
Presence of an implanted defibrillator
Pregnant of breastfeeding
Enrolled in another medication research study
On dialysis or underwent a kidney transplant
Using potentially cardiotoxic illicit drugs (e.g., cocaine, methamphetamine, opioids) in the 12 months prior to study entry
Active alcoholism
Underlying cardiovascular disease with alcoholic cardiomyopathy as the primary clinical diagnosis

Contacts and Locations

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

Contacts

Contact: Charles M. Stein

615-936-3420

Locations

United States, Tennessee
Vanderbilt Medical School	Recruiting
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

eCardio

Reliant Pharmaceuticals

Investigators

Principal Investigator:

Charles M. Stein

Vanderbilt Medical School

More Information

Responsible Party:	Vanderbilt Univeristy School of Medicine ( C. Michael Stein, MD )
Study ID Numbers:	543, HL 087254
Study First Received:	October 31, 2007
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00552084
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Fish Oil

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009