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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Fish oil

Placebo

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Fish Oil

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Vanderbilt Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish Oil

Placebo

Arm Description

4 grams fish oil daily for 24 weeks

corn oil taken daily for 24 weeks

Outcomes

Primary Outcome Measures

Documented Recurrence of Atrial Fibrillation/Atrial Flutter

Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.

Secondary Outcome Measures

Full Information

NCT ID

NCT00552084

First Posted

October 31, 2007

Last Updated

November 18, 2014

Sponsor

Vanderbilt University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), eCardio Diagnostics, GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00552084

Brief Title

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

Official Title

Fish Oil for Atrial Fibrillation - Effect and Mechanisms

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), eCardio Diagnostics, GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Fish Oil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

190 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fish Oil

Arm Type

Experimental

Arm Description

4 grams fish oil daily for 24 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

corn oil taken daily for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Fish oil

Other Intervention Name(s)

Lovaza capsule (1 gm)containing 465 mg EPA and 375 mg DHA.

Intervention Description

Fish oil supplements 4 gms will be taken daily for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Corn oil

Intervention Description

Placebo supplements will be taken daily for 24 weeks.

Primary Outcome Measure Information:

Title

Documented Recurrence of Atrial Fibrillation/Atrial Flutter

Description

Trans-telephonic electrocardiographic monitoring (TTM) device were used to send transmissions every 2 weeks and each time a participant had symptoms suggestive of arrhythmia.

Time Frame

Measured at Week 24 or exit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles M. Stein

Organizational Affiliation

Vanderbilt Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt Medical School

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25465932

Citation

Darghosian L, Free M, Li J, Gebretsadik T, Bian A, Shintani A, McBride BF, Solus J, Milne G, Crossley GH, Thompson D, Vidaillet H, Okafor H, Darbar D, Murray KT, Stein CM. Effect of omega-three polyunsaturated fatty acids on inflammation, oxidative stress, and recurrence of atrial fibrillation. Am J Cardiol. 2015 Jan 15;115(2):196-201. doi: 10.1016/j.amjcard.2014.10.022. Epub 2014 Oct 29.

Results Reference

derived

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

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