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

NCT00552084 | Completed Phase 4 Results DMC

• 3 other identifiers: 543R01HL087254HL 087254
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Fish Oil

Outcome Measures

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.

  Measured at Week 24 or exit

Study Arms (2)

Fish Oil

EXPERIMENTAL

4 grams fish oil daily for 24 weeks

Drug: Fish oil

Placebo

PLACEBO COMPARATOR

corn oil taken daily for 24 weeks

Drug: Placebo

Interventions

Fish oil DRUG

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.

Fish Oil

Placebo DRUG

Placebo supplements will be taken daily for 24 weeks.

Also known as: Corn oil

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• eCardio Diagnostics: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Vanderbilt Medical School

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• 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.

  PMID: 25465932 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Fish Oils; Omacor; Corn Oil

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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.

Results Point of Contact

• Title: Dr. C Michael Stein
• Organization: Vanderbilt University Medical Center

mike.stein@vanderbilt.edu

615-936-3420

Study Officials

• Charles M. Stein

  Vanderbilt Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 3, 2014
• Results First Posted: November 18, 2014

Record last verified: 2014-11

Locations

US (1)