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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Antonio Cittadini, Federico II University

ClinicalTrials.gov Identifier:

NCT01576861

First received: March 19, 2012

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 19, 2012
Last Updated Date	October 17, 2012
Start Date ^ICMJE	January 2007
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 12, 2012)	Peak Oxygen Consumption [ Time Frame: after 48 months ] [ Designated as safety issue: No ] Side effects [ Time Frame: Any side effects recorded after 6,24 and 48 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: April 12, 2012)	Peak of Oxygen Consumption [ Time Frame: after 48 months ] [ Designated as safety issue: No ] Side effects [ Time Frame: Any side effects recorded after 6,24 and 48 months ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT01576861 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 16, 2012)	Left Ventricular Ejection Fraction [ Time Frame: after 48 months ] [ Designated as safety issue: No ] Left Ventricular End-Systolic Volume [ Time Frame: after 48 months ] [ Designated as safety issue: No ] Left Ventricular End-Diastolic Volume [ Time Frame: after 48 months ] [ Designated as safety issue: No ] Quality of Life [ Time Frame: after 48 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Growth Hormone Deficiency Chronic Heart Failure
Intervention ^ICMJE	Drug: Somatotropin Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
Study Arm (s)	Experimental: 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 Intervention: Drug: Somatotropin No Intervention: Control CHF patients under optimized CHF therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date	December 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01576861
Other Study ID Numbers ^ICMJE	Long-Term GH in CHF
Has Data Monitoring Committee	Not Provided
Responsible Party	Antonio Cittadini, Federico II University
Study Sponsor ^ICMJE	Federico II University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Federico II University
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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