Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery (FISH)

September 12, 2018 updated by: Chirag Sandesara

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52246
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
olive oil
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.
Other Names:
  • Lovaza, Omega three polyunsaturate ethyl esters
Experimental: fish oil , corn oil
Highly purified pharmaceutical grade omega three polyunsaturated fatty acids
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.
Other Names:
  • Lovaza, Omega three polyunsaturate ethyl esters

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chirag Sandesara

Collaborators

GlaxoSmithKline

Investigators

  • Study Chair: Chirag M Sandesara, MD, Virginia Cardiovascular Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1733860001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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