Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT00446966

Run by

Chirag Sandesara

People needed

260

Starts

2007-02-01

Expected to finish

2010-01-01

Last updated by the study team

2018-10-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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