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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00446966
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Chirag Sandesara, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Omega Three Polyunsaturated fatty acids Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial
Study Start Date : February 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

Arm Intervention/treatment
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 Name: Lovaza, Omega three polyunsaturate ethyl esters

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 Name: Lovaza, Omega three polyunsaturate ethyl esters




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446966


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Chirag Sandesara
GlaxoSmithKline
Investigators
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Study Chair: Chirag M Sandesara, MD Virginia Cardiovascular Associates
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chirag Sandesara, MD, University of Iowa
ClinicalTrials.gov Identifier: NCT00446966    
Other Study ID Numbers: 1733860001
First Posted: March 13, 2007    Key Record Dates
Results First Posted: October 10, 2018
Last Update Posted: October 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chirag Sandesara, University of Iowa:
atrial fibrillation
coronary artery disease bypass graft surgery
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes