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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federico II University
• Treatments: Hormones

Criteria

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)