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CompletedNCT00552084Updated Dec 3, 2014Results posted

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

A Phase 4 interventional study of Fish oil and Placebo in Atrial Fibrillation, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by Vanderbilt University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Fish Oil
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 190 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
190 participants (actual)

Study arms

  • Experimental
    Fish Oil

    4 grams fish oil daily for 24 weeks

    Drug: Fish oil

  • Placebo comparator
    Placebo

    corn oil taken daily for 24 weeks

    Drug: Placebo

Interventions

  • DrugFish oil

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

    Also known as: Lovaza capsule (1 gm)containing 465 mg EPA and 375 mg DHA.

  • DrugPlacebo

    Placebo supplements will be taken daily for 24 weeks.

    Also known as: Corn oil

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Measured at Week 24 or exit

07

Results

Posted Nov 18, 2014
Limitations and caveats
We determined recurrence of Atrial Fibrillation(AF) by both routine and symptomatic TTM transmissions. We did not examine the effect of therapy on total AF burden. Sample size was relatively small, and included a heterogeneous patient population.

Participant flow

Participants were recruited at 4 medical centers in Nashville Tennessee, and at the Marsh field Clinic in Madison, Wisconsin. Between December 2007 and December 2012, 241 patients were enrolled and 190 (178 at Vanderbilt, 12 at other sites) were randomized to fish oil (126) or placebo (64). Of 190 enrolled, 173 (91%) completed the study.

Participant flow — Overall Study
MilestoneFish OilPlacebo
Started12664
Completed11855
Not completed89
Withdrew: Adverse event23
Withdrew: Withdrawal by subject45
Withdrew: Protocol violation10
Withdrew: Change in anti-arrythmic drug11

Outcome measures

PrimaryDocumented 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.

Time frame:
Measured at Week 24 or exit
Reported as:
Number · percentage of participants
Documented Recurrence of Atrial Fibrillation/Atrial Flutter
percentage of participantsFish OilPlacebo
Documented Recurrence of Atrial Fibrillation/Atrial Flutter5947

Adverse events

Collected over Adverse event data were collected during the 24 week study, after participants took first dose of study medication or placebo.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fish Oil—2/126 (1.6%)40/126 (31.7%)
Placebo—3/64 (4.7%)13/64 (20.3%)
Most frequent serious events
Most frequent serious events
EventFish OilPlacebo
acute coronary syndromeCardiac disorders0/1261/64
bradycardiaCardiac disorders0/1261/64
rapid atrial fibrillationCardiac disorders0/1261/64
pseudogoutMusculoskeletal and connective tissue disorders1/1260/64
non-cardiac chest painGeneral disorders1/1260/64
Most frequent other events
Most frequent other events
EventFish OilPlacebo
Low INRBlood and lymphatic system disorders17/1262/64
Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders11/1268/64
DiarrheaGastrointestinal disorders6/1261/64
NauseaGastrointestinal disorders6/1262/64

Baseline characteristics

Age, Continuous
Age, Continuous(years)Fish OilPlaceboTotal
Mean61.9 (21 to 82)61.5 (28 to 82)61.7 (21 to 82)
Age, Categorical
Age, Categorical(Participants)Fish OilPlaceboTotal
<=18 years000
Between 18 and 65 years6238100
>=65 years642690
Sex: Female, Male
Sex: Female, Male(Participants)Fish OilPlaceboTotal
Female592281
Male6742109
Region of Enrollment
Region of Enrollment(participants)Fish OilPlaceboTotal
United States12664190
08

Study locations

1 site
  • Vanderbilt Medical School
    Nashville, Tennessee 37232, United States
09

References and documents

Publications

  • Vanderbilt C, 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. PubMed 25465932 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00552084
Lead sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), eCardio Diagnostics, GlaxoSmithKline
Responsible party
C. Michael Stein (Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, Vanderbilt University) — Principal investigator
First posted
Nov 1, 2007
Start date
Nov 2007
Primary completion
Apr 2014
Completion
Apr 2014
Results posted
Nov 18, 2014
Last update
Dec 3, 2014

Study contacts

Charles M. Stein
principal investigator · Vanderbilt Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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