Fish Oil for Reduction of Atrial Fibrillation After Cardiac Surgery

NCT00446966 | Completed Phase 4 Results DMC

• 1 other identifier: 1733860001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; coronary artery disease bypass graft surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Study Arms (2)

fish oil , corn oil

EXPERIMENTAL

Highly purified pharmaceutical grade omega three polyunsaturated fatty acids

Drug: Omega Three Polyunsaturated fatty acids

placebo

PLACEBO COMPARATOR

olive oil

Drug: Omega Three Polyunsaturated fatty acids

Interventions

Omega Three Polyunsaturated fatty acids DRUG

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

Also known as: Lovaza, Omega three polyunsaturate ethyl esters

fish oil , corn oil; placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chirag Sandesara: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52246, United States

Location

Related Publications (1)

• 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.

  PMID: 23130134 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Omacor

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Chirag Sandesara
• Organization: Carient Heart and Vascular

csandesara@carient.org

7033358750

Study Officials

• Chirag M Sandesara, MD

  Virginia Cardiovascular Associates

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: October 10, 2018
• Results First Posted: October 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)