Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging (OmegaREMODEL)

May 25, 2017 updated by: Raymond Y. Kwong, MD, Brigham and Women's Hospital

Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction

Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A new MRI technique to examine the heart was recently developed. In this study, researchers will use this new technique to evaluate the heart in people who have recently had a heart attack to determine whether a specific pattern of heart muscle damage is related to sudden cardiac death. This fatal condition, also known as cardiac arrest, occurs when the heart abruptly stops pumping blood to the body, resulting in loss of consciousness, absence of pulse, and a stop in breathing. The most common cause of sudden cardiac death is a heart attack.

In addition to evaluating the new heart MRI technique, this study will also examine the effects of fish oil supplementation in people who have recently had a heart attack. Recent research has shown that omega-3 fatty acids, commonly found in fish oil, may be beneficial for people with heart conditions. Lastly, the study will determine whether specific biomarkers and genetic factors can help predict the likelihood of a person dying from sudden cardiac death after previously experiencing a heart attack.

Apart from studying the likelihood of sudden cardiac death, This study will measure the change in structure and pumping function of the heart (known as ventricular remodeling) and this study will determine if the high dose of fish oil treatment will result in an improvement of the heart.

This study will enroll people who have had a heart attack in the 2 to 4 weeks before study entry. At a baseline study visit, participants will undergo an MRI of their heart and complete an exercise stress test on a treadmill. A blood sample will be collected, and women will provide a urine sample for a pregnancy test. Questionnaires asking about diet, medical history, and emotions will also be completed. Participants will then be randomly assigned to receive either fish oil supplements or placebo on a daily basis for 6 months. Every 2 to 3 months, study researchers will call participants to check on their health and progress. At a study visit at Month 6, participants will undergo repeat baseline testing. After this visit, study researchers will call participants every 6 months for 3 years to follow up on participants' health status.

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 3

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, Shapiro Cardiovascular Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Experienced a heart attack in the 2 to 4 weeks before study entry
  • Lives in the greater Boston area or adjacent regions (within a 50-mile radius of Boston)

Exclusion Criteria:

  • Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an implantable cardioverter defibrillator [AICD]) at time of study entry
  • Active cancer or any other terminal illness with an expected survival rate of less than 6 months after study entry
  • Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than 60 mL/min in the 2 weeks before study entry
  • Inability to follow study procedures
  • Pregnant
  • Hemodynamic instability
  • Urgent clinical need for a pacemaker or AICD
  • Inaccessibility of medical records

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 Fatty Acids
Participants will receive a highly purified form of omega-3 fatty acids for 6 months.
Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
4 grams of omega-3 fatty acids taken orally once per day for 6 months
Other Names:
  • Lovaza (GlaxoSmithKline)
Placebo Comparator: Placebo
Participants will receive placebo for 6 months.
Drug: Placebo
Placebo tablets taken orally once per day for 6 months
Other Names:
  • Corn oil placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling
Time Frame: Before and after study treatments
Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)
Before and after study treatments

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis
Time Frame: Measured in the 3-year follow-up period after participant's last study visit
Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)
Measured in the 3-year follow-up period after participant's last study visit
Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction
Time Frame: Measured in the 3-year follow-up period after participant's last study visit
Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)
Measured in the 3-year follow-up period after participant's last study visit
Effect of Omega-3 Fatty Acids on Infarct Size
Time Frame: Measured in the 3-year follow-up period after participant's last study visit
Measured as change in infarct size from baseline to post-treatment (6-months)
Measured in the 3-year follow-up period after participant's last study visit

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline

Investigators

  • Principal Investigator: Raymond Y. Kwong, MD, MPH, Brigham and Women's Hospital

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

August 1, 2008

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 591
  • R01HL091157-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share data with GISSI Heart Failure group for pooling and meta-analysis

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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