Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

Atrial Fibrillation Clinical Trial

— FISH  

Official title:

Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446966
• Other study ID #: 1733860001
• Status: Completed
• Phase: Phase 4
• Start date: February 2007
• Est. completion date: January 2010

Study information

• Verified date: September 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Omega Three Polyunsaturated fatty acids
2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Chirag Sandesara	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Developed Postoperative Atrial Fibrillation	The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.	14 days