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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01576861 |
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Date of registration:
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19/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
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Scientific title:
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Date of first enrolment:
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January 2007 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01576861 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Heart Failure
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Somatotropin
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Primary Outcome(s)
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Side effects
[Time Frame: Any side effects recorded after 6,24 and 48 months]
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Peak Oxygen Consumption
[Time Frame: after 48 months]
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Secondary Outcome(s)
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Left Ventricular Ejection Fraction
[Time Frame: after 48 months]
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Left Ventricular End-Systolic Volume
[Time Frame: after 48 months]
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Left Ventricular End-Diastolic Volume
[Time Frame: after 48 months]
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Quality of Life
[Time Frame: after 48 months]
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Secondary ID(s)
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Long-Term GH in CHF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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