Back to resultsLong-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Primary Purpose
Growth Hormone Deficiency, Chronic Heart Failure
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Somatotropin
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Deficiency
Eligibility Criteria
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)
Sites / Locations
- Department of Internal Medicine, Cardiovascular and Immunological Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GH replacement
Control CHF patients under optimized CHF therapy
Arm Description
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
Outcomes
Primary Outcome Measures
Peak Oxygen Consumption
Side effects
Secondary Outcome Measures
Left Ventricular Ejection Fraction
Left Ventricular End-Systolic Volume
Left Ventricular End-Diastolic Volume
Quality of Life
Full Information
NCT ID
NCT01576861
First Posted
March 19, 2012
Last Updated
October 17, 2012
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT01576861
Brief Title
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency, Chronic Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GH replacement
Arm Type
Experimental
Arm Description
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
Arm Title
Control CHF patients under optimized CHF therapy
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Somatotropin
Intervention Description
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
Primary Outcome Measure Information:
Title
Peak Oxygen Consumption
Time Frame
after 48 months
Title
Side effects
Time Frame
Any side effects recorded after 6,24 and 48 months
Secondary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Time Frame
after 48 months
Title
Left Ventricular End-Systolic Volume
Time Frame
after 48 months
Title
Left Ventricular End-Diastolic Volume
Time Frame
after 48 months
Title
Quality of Life
Time Frame
after 48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Internal Medicine, Cardiovascular and Immunological Sciences
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Long-Term Efficacy and Safety of Growth Hormone Replacement Therapy in Chronic Heart Failure
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