Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Federico II University

Status and phase: Completed; Phase 2

Conditions: Ischemic Heart Disease; Heart Failure; Growth Hormone Deficiency

Treatments: Drug: Somatotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT00591760

GH replacement in CHF

Details and patient eligibility

About

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.

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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

Enrollment: 56 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

GH

Experimental group

Description:

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

Treatment:

Drug: Somatotropin

Placebo

No Intervention group

Description:

PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment