Clinical trial NCT01534663: Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
Official title: Effects of Glutamine and Fish Oil on Muscle Function in Heart Failure (GlutFish-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: Heart Failure
Skeletal Muscle Function
Metabolism
Inflammation
Glutamine
Fish oil
Muscle Function
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Baseline Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
timeFrame: Baseline
measure: 90 Day Skeletal Muscle Function Capacity- Isometric Contractions (PKTQ/BW)
timeFrame: 90 Days
measure: Baseline Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
timeFrame: Baseline
measure: 90 Day Muscle Function Capacity- Isokinetic Contractions (PKTQ/BW)
timeFrame: 90 Days
measure: Baseline Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
timeFrame: Baseline
measure: 90 Days Muscle Function Capacity- Isokinetic Contractions (Work (WK)/Body Weight (BW))
timeFrame: 90 Days
measure: Baseline Muscle Function Capacity- Isokinetic Contractions (Total Work)
timeFrame: Baseline
measure: 90 Day Muscle Function Capacity- Isokinetic Contractions (Total Work)
timeFrame: 90 Days
measure: Baseline Muscle Function Capacity- Isokinetic Contractions (Average Power)
timeFrame: Baseline
measure: 90 Day Muscle Function Capacity- Isokinetic Contractions (Average Power)
timeFrame: 90 Days
measure: Baseline Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
timeFrame: Baseline
measure: 90 Day Muscle Function Capacity- Isokinetic Contractions (Time to Peak Torque)
timeFrame: 90 Days
measure: Percent Change in Peak Effort Oxygen Consumption
timeFrame: Baseline to 90 Days
Secondary outcomes:
measure: Baseline Systemic and Local Inflammation
timeFrame: Baseline
measure: 90 Day Systemic and Local Inflammation
timeFrame: 90 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Paolo C. Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahzad K, Chokshi A, Schulze PC. Supplementation of glutamine and omega-3 polyunsaturated fatty acids as a novel therapeutic intervention targeting metabolic dysfunction and exercise intolerance in patients with heart failure. Curr Clin Pharmacol. 2011 Nov;6(4):288-94. doi: 10.2174/157488411798375958.
citation: Wu C, Kato TS, Ji R, Zizola C, Brunjes DL, Deng Y, Akashi H, Armstrong HF, Kennel PJ, Thomas T, Forman DE, Hall J, Chokshi A, Bartels MN, Mancini D, Seres D, Schulze PC. Supplementation of l-Alanyl-l-Glutamine and Fish Oil Improves Body Composition and Quality of Life in Patients With Chronic Heart Failure. Circ Heart Fail. 2015 Nov;8(6):1077-87. doi: 10.1161/CIRCHEARTFAILURE.115.002073. Epub 2015 Aug 12.