Omega-Three Fatty Acids for the Prevention of Atrial Fibrillation After Cardiac Surgery - Full Text View

Sponsors and Collaborators:	University of Iowa The Cleveland Clinic St Luke's Hospital - Mid America Heart Institute Carolinas Healthcare System University of Tennessee Cancer Institute Reliant Pharmaceuticals
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00446966

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Omega-3 acid ethyl ester	Phase IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Heart Surgery

Drug Information available for: Omacor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Omega-Three Fatty Acids for the Prevention of Atrial Fibrillation After Cardiac Surgery

Further study details as provided by University of Iowa:

Primary Outcome Measures:

The primary endpoint is the development of postoperative atrial fibrillation or flutter 14 days after bypass surgery.

Secondary Outcome Measures:

ICU and hospital lengths of stay; Reoperation; Re-hospitalization for any cardiovascular problem; Time in atrial fibrillation; Atrial fibrillation occurring between postoperative days 1-5; Death.

Estimated Enrollment:	250
Study Start Date:	February 2007
Estimated Study Completion Date:	April 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-85 years old.
Elective coronary 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446966

Contacts

Contact: Chirag M Sandesara, MD	319-356-2585	chirag-sandesara@uiowa.edu
Contact: Brian Olshansky, MD	319-356-2344	brian-olshansky@uiowa.edu

Locations

United States, Iowa
University of Iowa Hospitals and Clinics	Recruiting
Iowa City, Iowa, United States, 52246
Contact: Chirag M Sandesara, MD 319-356-2585 chirag-sandesara@uiowa.edu
Contact: Brian Olshansky, MD 319-356-2344 brian-olshansky@uiowa.edu
Principal Investigator: Chirag Sandesara, MD

Sponsors and Collaborators

University of Iowa

The Cleveland Clinic

St Luke's Hospital - Mid America Heart Institute

Carolinas Healthcare System

University of Tennessee Cancer Institute

Reliant Pharmaceuticals

More Information

Study ID Numbers:	1733860001
Study First Received:	March 12, 2007
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00446966
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Iowa:

atrial fibrillation
coronary artery disease bypass graft surgery

Study placed in the following topic categories:

Coronary Disease
Heart Diseases
Atrial Fibrillation
Coronary Artery Disease
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009