Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Study Overview
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Brief Summary
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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
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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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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).

Official Title
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Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study

Conditions
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Heart Failure, Growth Hormone Deficiency, Ischemic Heart Disease

Intervention / Treatment
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* Drug: Somatotropin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GH<br>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 | Drug: Somatotropin<br>* Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months<br>* Other names: NutropinAq;|
| No Intervention: Placebo<br>PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak VO2 | changes in peak VO2 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Growth Hormone, Anabolism, Anabolic Deficiency, Hormone replacement