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

Phase 2

Completed

• Conditions: Growth Hormone Deficiency; Chronic Heart Failure
• Interventions: Drug: Somatotropin

• Registration Number: NCT01576861
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2011-03
• Study Completion: 2011-12
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GH replacement	Somatotropin	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

Primary Outcome Measures

Name	Time	Method
Peak Oxygen Consumption	after 48 months
Side effects	Any side effects recorded after 6,24 and 48 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	after 48 months
Left Ventricular Ejection Fraction	after 48 months
Left Ventricular End-Systolic Volume	after 48 months
Left Ventricular End-Diastolic Volume	after 48 months

Trial Locations

Locations (1)

Department of Internal Medicine, Cardiovascular and Immunological Sciences; 🇮🇹 Napoli, Campania, Italy