Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Primary Endpoint
- Peak VO2
Study Overview
Brief Summary
The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.
Detailed Description
To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).
Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.
Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Heart Failure in ew York Heart Association functional class II to IV
- •Left ventricular end diastolic diameter > 60 mm
- •Left ventricular ejection fraction < 40%
- •Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/dl)
- •Age 18-80 years
- •Clinical stability, guideline-oriented maximal pharmacological therapy
- •Informed consent
Exclusion Criteria
- •Active Myocarditis
- •Hypertrophic Cardiomyopathy
- •Active endocarditis
- •Active malignancy
- •End stage renal disease
- •Severe liver disease (Child B-C)
Arms & Interventions
GH
Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0.012 mg/kg every second day, added to their background optimized CHF therapy
Intervention: Somatotropin (Drug)
Outcomes
Primary Outcomes
Peak VO2
Time Frame: 6 months
changes in peak VO2
Secondary Outcomes
No secondary outcomes reported