Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure

Last updated: November 26, 2020
Sponsor: Columbia University
Overall Status: Completed

Phase

2/3

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT01534663
AAAE8356
  • Ages 35-80
  • All Genders

Study Summary

The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age greater than 18 years,
  • left ventricular ejection fraction less than or equal to 35%,
  • stable on standard HF medications, and
  • optimal medical therapy.

Exclusion

Exclusion Criteria:

  • major cardiovascular events,
  • procedures in the last 6 months,
  • dementia,
  • presence of cardiovascular diseases that may lead to harm if the patient took part inthe study (congenital heart disease, long QT syndrome, hypertrophic cardiomyopathy,active myocarditis).

Study Design

Total Participants: 31
Study Start date:
November 01, 2011
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Medical Center

    New York City, New York 10032
    United States

    Site Not Available

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