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

Columbia University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Heart Failure

Treatments

Drug: Glutamine and Fish Oil Supplementation

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01534663

AAAE8356

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

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).