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Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure (GLUTFISH-HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Schulze, Columbia University
ClinicalTrials.gov Identifier:
NCT01534663
First received: February 14, 2012
Last updated: July 5, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Glutamine and Fish Oil Supplementation
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Skeletal Muscle Function [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Systemic and Local Inflammation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    A secondary outcome is the measurement of systemic and local markers of inflammation.


Enrollment: 31
Study Start Date: November 2011
Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
The placebo for fish oil will be safflower oil. For glutamine, soy powder will serve as the placebo.
Drug: Placebo
This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.
Active Comparator: Glutamine/Fishoil
3.285 g of EPA and 3.285 g of DHA and L-alanyl-glutamine (8g/d).
Drug: Glutamine and Fish Oil Supplementation
This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 in the study (congenital heart disease, long QT syndrome, hypertrophic cardiomyopathy, active myocarditis).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534663

Locations
United States, New York
Columbia University Medical Center
New York City, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Paul Christian Schulze, MD, PhD Columbia University
  More Information

Publications:
Responsible Party: Christian Schulze, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01534663     History of Changes
Other Study ID Numbers: AAAE8356
Study First Received: February 14, 2012
Last Updated: July 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Heart Failure
Skeletal Muscle Function
Metabolism
Inflammation
Glutamine
Fish oil
Muscle Function

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014