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The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure

NCT00944229 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-05-25

Study results available
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Summary

A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure patients suggested that omega 3 may lower the risk of death from CHF. The mechanism of this potential benefit is not well understood.

Methods:

Forty patients will be enrolled in the study. Twenty patients will receive Omega 3 (lovaza 4 gm a day) and 20 patients will receive placebo. All subjects will have assessment of their exercise capacity and blood vessel function before and after an 8 week treatment period. About 4 table spoons of blood will be drawn throughout the study.

Expected results:

The investigators believe that omega 3 may improve the ability to exercise and improve blood vessel function.

Conditions

Interventions

DRUG

LOVAZA (Omega-3)

LOVAZA 4 gm q24 for 8 weeks Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).

DRUG

Placebo

4 capsules of placebo every 24 hours

Sponsors & Collaborators

Principal Investigators

  • Ulrich Jorde, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944229 on ClinicalTrials.gov