- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00552084
Evaluating the Effectiveness of Fish Oil Supplements at Reducing the Recurrence of Atrial Fibrillation
Fish Oil for Atrial Fibrillation - Effect and Mechanisms
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish Oil
4 grams fish oil daily for 24 weeks
|
Fish oil supplements 4 gms will be taken daily for 24 weeks.
Other Names:
|
Placebo Comparator: Placebo
corn oil taken daily for 24 weeks
|
Placebo supplements will be taken daily for 24 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Documented Recurrence of Atrial Fibrillation/Atrial Flutter
Time Frame: Measured at Week 24 or exit
|
Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.
|
Measured at Week 24 or exit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles M. Stein, Vanderbilt Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 543
- R01HL087254 (U.S. NIH Grant/Contract)
- HL 087254
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Fish oil
-
University of CopenhagenAnjo A/SCompletedObesity | Cardiovascular Disease | Metabolic Syndrome | Growth | Blood Pressure
-
DSM Nutritional Products, Inc.Completed
-
Rigshospitalet, DenmarkDanish Child Cancer FoundationRecruitingLeukemia, Acute LymphoblasticDenmark
-
National Science Council, TaiwanCompletedMajor Depressive DisorderTaiwan
-
Tufts UniversityPrevention PharmaceuticalsTerminated
-
Liverpool John Moores UniversityCompleted
-
Stanford UniversityNordic NaturalsCompleted
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedProteomics | Lipoprotein Metabolism | PCSK9United States
-
National Heart, Lung, and Blood Institute (NHLBI)UnknownMyocardial Tissue in Heart Transplantation
-
Melbourne HealthCompleted