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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00729430
First Posted: August 7, 2008
Last Update Posted: June 1, 2017
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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital
Results First Submitted: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Myocardial Infarction
Death, Sudden, Cardiac
Interventions: Drug: Omega-3 Fatty Acids (Fish Oil Supplements)
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Dose Omega-3 Fatty Acid Arm

Participants will receive a highly purified form of omega-3 fatty acids for 6 months.

Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months

Placebo Arm

Participants will receive placebo for 6 months.

Placebo: Placebo tablets taken orally once per day for 6 months


Participant Flow:   Overall Study
    High Dose Omega-3 Fatty Acid Arm   Placebo Arm
STARTED   180   178 
COMPLETED   133   128 
NOT COMPLETED   47   50 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Omega-3 Fatty Acid Arm

Participants will receive a highly purified form of omega-3 fatty acids for 6 months.

Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months

Placebo Arm

Participants will receive placebo for 6 months.

Placebo: Placebo tablets taken orally once per day for 6 months

Total Total of all reporting groups

Baseline Measures
   High Dose Omega-3 Fatty Acid Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 180   178   358 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (10)   58  (10)   59  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32  17.8%      38  21.3%      70  19.6% 
Male      148  82.2%      140  78.7%      288  80.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   180   178   358 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling   [ Time Frame: Before and after study treatments ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was not powered to evaluate for clinical heart failure and hard cardiac outcomes. A prospective trial would be necessary to determine the effect of earlier and high-dose omega-3 fatty acid therapy on improving clinical outcomes.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Raymond Y. Kwong, Director of Cardiac Magnetic Resonance Imaging
Organization: Brigham and Women's Hospital
phone: 857-307-1960
e-mail: rykwong@partners.org


Publications of Results:
Other Publications:

Responsible Party: Raymond Y. Kwong, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00729430     History of Changes
Other Study ID Numbers: 591
R01HL091157-01 ( U.S. NIH Grant/Contract )
First Submitted: August 4, 2008
First Posted: August 7, 2008
Results First Submitted: February 28, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017