Heart Failure Clinical Trial
Official title:
Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
Verified date | March 2009 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics CommitteeItaly: Ministry of Health |
Study type | Interventional |
The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.
Status | Completed |
Enrollment | 56 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Heart Failure in ew York Heart Association functional class II to IV - Left ventricular end diastolic diameter > 60 mm - Left ventricular ejection fraction < 40% - Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/dl) - Age 18-80 years - Clinical stability, guideline-oriented maximal pharmacological therapy - Informed consent Exclusion Criteria: - Active Myocarditis - Hypertrophic Cardiomyopathy - Active endocarditis - Active malignancy - End stage renal disease - Severe liver disease (Child B-C) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak VO2 | changes in peak VO2 | 6 months | No |
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