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

Chronic Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576861
• Other study ID #: Long-Term GH in CHF
• Status: Completed
• Phase: Phase 2
• First received: March 19, 2012
• Last updated: October 17, 2012
• Start date: January 2007
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Dwarfism, Pituitary
• Growth Hormone Deficiency
• Heart Failure

Intervention

Drug:
• Somatotropin
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day

Locations

Country	Name	City	State
Italy	Department of Internal Medicine, Cardiovascular and Immunological Sciences	Napoli	Campania

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen Consumption		after 48 months	No
Primary	Side effects		Any side effects recorded after 6,24 and 48 months	Yes
Secondary	Left Ventricular Ejection Fraction		after 48 months	No
Secondary	Left Ventricular End-Systolic Volume		after 48 months	No
Secondary	Left Ventricular End-Diastolic Volume		after 48 months	No
Secondary	Quality of Life		after 48 months	No

External Links

•   preliminary short term data