Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

NCT ID: NCT00446966

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-01-31

Brief Summary

The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.

Detailed Description

Atrial fibrillation is the most common complication after bypass surgery. It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortality. Atrial fibrillation is also associated with an increased risk for strokes, use of potentially harmful drugs, and the need for pacemaker therapy.

This study is for patients who are undergoing elective bypass surgery. Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo, prior to surgery. After surgery, treatment will continue until the primary endpoint, atrial fibrillation, is reached, or 14 days, whichever is first.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

fish oil , corn oil

Highly purified pharmaceutical grade omega three polyunsaturated fatty acids

Group Type: EXPERIMENTAL

Omega Three Polyunsaturated fatty acids

Intervention Type: DRUG

2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.

placebo

olive oil

Group Type: PLACEBO_COMPARATOR

Omega Three Polyunsaturated fatty acids

Intervention Type: DRUG

2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.

Interventions

Omega Three Polyunsaturated fatty acids

2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.

Intervention Type: DRUG

Other Intervention Names

Lovaza, Omega three polyunsaturate ethyl esters

Eligibility Criteria

Inclusion Criteria

• Age 18-85 years old.
• Elective coronary artery bypass (CABG) operation with or without concomitant valve surgery planned for at least 2 days after enrollment.
• Signed, documented informed consent prior to admission to the study.

Exclusion Criteria

• Urgent or emergent bypass required to be performed <24 hrs after screening.
• Unstable angina, requiring intervention or CABG <24 hrs after screening.
• Decompensated congestive heart failure.
• Chronic, persistent atrial fibrillation - patient in atrial fibrillation at the time of screening or enrollment or scheduled for a maze procedure or pulmonary vein isolation at the time of surgery.
• Known sensitivity to Omacor (0mega-3 acid ethyl esters) and hypersensitivity to fish, fish products or corn oil.
• Patients requiring warfarin or Lovenox the 2 days prior to bypass surgery.
• Patients on Class I or III antiarrhythmic agents (quinidine, procainamide, disopyramide, flecainide, propafenone, moricizine, dofetilide, sotalol, amiodarone) or who have taken these drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone).
• Patients who are pregnant or nursing.
• Patients unable to provide/sign informed consent.
• Patients currently enrolled in another clinical trial without a 30 day washout period.
• Patients currently taking marine based omega-three fish oil supplements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Chirag Sandesara

OTHER

Sponsor Role: lead

Responsible Party

Chirag Sandesara

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chirag M Sandesara, MD

Role: STUDY_CHAIR

Virginia Cardiovascular Associates

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Countries

United States

References

Sandesara CM, Chung MK, Van Wagoner DR, Barringer TA, Allen K, Ismail HM, Zimmerman B, Olshansky B. A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids for Inhibition of Supraventricular Arrhythmias After Cardiac Surgery: The FISH Trial. J Am Heart Assoc. 2012 Jun;1(3):e000547. doi: 10.1161/JAHA.111.000547. Epub 2012 Jun 22.

Reference Type: DERIVED

PMID: 23130134 (View on PubMed)

Other Identifiers

1733860001

Identifier Type: -

Identifier Source: org_study_id