Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery (FISH)
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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 Three Polyunsaturated fatty acids |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Fish Oil to Inhibit Supraventricular Arrhythmias After Cardiac Surgery: The Fish Trial |
- The primary endpoint is the development of postoperative atrial fibrillation or flutter after bypass surgery. [ Time Frame: 14 days ] [ Designated as safety issue: No ]The primary outcome in this study is post-bypass atrial fibrillation documented by ECG or rhythm strip and requiring treatment.
- Time to post-operative atrial fibrillation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]ICU and hospital lengths of stay, re-operation; bleeding, stroke, peri-operative myocardial infarction, re-hospitalization for any cardiovascular problem, Time to atrial fibrillation, Death.
| Enrollment: | 260 |
| Study Start Date: | February 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 oraly daily after until primary endpoint or 14 days.
Other Name: Lovaza, Omega three polyunsaturate ethyl esters
|
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 |
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| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52246 | |
| Study Chair: | Chirag M Sandesara, MD | Virginia Cardiovascular Associates |
More Information
No publications provided
| Responsible Party: | Chirag M Sandesara, Virginia Cardiovascular Associates |
| ClinicalTrials.gov Identifier: | NCT00446966 History of Changes |
| Other Study ID Numbers: | 1733860001 |
| Study First Received: | March 12, 2007 |
| Last Updated: | May 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Iowa:
|
atrial fibrillation coronary artery disease bypass graft surgery |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013