Chronic Heart Failure, Growth Hormone Deficiency
Conditions
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.
Interventions
DRUGSomatotropin
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Oxygen Consumption | after 48 months |
| Side effects | Any side effects recorded after 6,24 and 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fraction | after 48 months |
| Left Ventricular End-Systolic Volume | after 48 months |
| Left Ventricular End-Diastolic Volume | after 48 months |
| Quality of Life | after 48 months |
Countries
Italy
Outcome results
None listed