Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
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ClinicalTrials.gov Identifier: NCT00591760 |
Recruitment Status :
Completed
First Posted : January 11, 2008
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 20, 2007 | ||||||
First Posted Date ICMJE | January 11, 2008 | ||||||
Results First Submitted Date ICMJE | March 23, 2009 | ||||||
Results First Posted Date ICMJE | November 19, 2012 | ||||||
Last Update Posted Date | November 19, 2012 | ||||||
Study Start Date ICMJE | December 2004 | ||||||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Peak VO2 [ Time Frame: 6 months ] changes in peak VO2
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial | ||||||
Official Title ICMJE | Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study | ||||||
Brief Summary | 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. | ||||||
Detailed Description | To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test). Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life. Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP). |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Somatotropin
Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
56 | ||||||
Original Actual Enrollment ICMJE |
26 | ||||||
Actual Study Completion Date ICMJE | November 2007 | ||||||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00591760 | ||||||
Other Study ID Numbers ICMJE | GH replacement in CHF | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Antonio Cittadini, Federico II University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Federico II University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Federico II University | ||||||
Verification Date | March 2009 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |