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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Omega Three Polyunsaturated fatty acids

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, coronary artery disease bypass graft surgery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

fish oil , corn oil

placebo

Arm Description

Highly purified pharmaceutical grade omega three polyunsaturated fatty acids

olive oil

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00446966

First Posted

March 12, 2007

Last Updated

September 12, 2018

Sponsor

Chirag Sandesara

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00446966

Brief Title

Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

Acronym

FISH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chirag Sandesara

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

atrial fibrillation, coronary artery disease bypass graft surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fish oil , corn oil

Arm Type

Experimental

Arm Description

Highly purified pharmaceutical grade omega three polyunsaturated fatty acids

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

olive oil

Intervention Type

Drug

Intervention Name(s)

Omega Three Polyunsaturated fatty acids

Other Intervention Name(s)

Lovaza, Omega three polyunsaturate ethyl esters

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants Who Developed Postoperative Atrial Fibrillation

Description

The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chirag M Sandesara, MD

Organizational Affiliation

Virginia Cardiovascular Associates

Official's Role

Study Chair

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52246

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23130134

Citation

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.

Results Reference

derived

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Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

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