Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
NCT ID: NCT01576861
Last Updated: 2012-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2007-01-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GH replacement
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
Somatotropin
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
Control CHF patients under optimized CHF therapy
No interventions assigned to this group
Interventions
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Somatotropin
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Antonio Cittadini
Associate Professor
Locations
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Department of Internal Medicine, Cardiovascular and Immunological Sciences
Napoli, Campania, Italy
Countries
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Other Identifiers
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Long-Term GH in CHF
Identifier Type: -
Identifier Source: org_study_id