Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure

Federico II University

Status and phase: Completed; Phase 2

Conditions: Chronic Heart Failure; Growth Hormone Deficiency

Treatments: Drug: Somatotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT01576861

Long-Term GH in CHF

Details and patient eligibility

About

After the encouraging results of 6 months of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency (NCT00591760) the investigators wanted to collect data about the long-term efficacy and safety of this kind of therapy.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Heart Failure New York Heart Association functional class II to IV, secondary to ischemic or idiopathic cardiomyopathy
• Age range 18-80 years
• Stable medication for at least one month including beta-blockers that had to be started at least 5 months before entering the study
• Left Ventricular ejection fraction 40% or less
• Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/ml)
• Written Informed consent

Exclusion criteria

• Acute proliferative or severe non-proliferative diabetic retinopathy
• Active malignancy
• Evidence of progression or recurrence of an underlying intracranial tumor
• Unstable Angina or recent myocardial infarction
• Serum Creatinine levels > 2.5 mg/dl
• Severe liver disease (Child-Pugh B-C)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

GH replacement

Experimental group

Description:

Patients will receive 48 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

Control CHF patients under optimized CHF therapy

No Intervention group