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

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ClinicalTrials.gov Identifier: NCT01576861
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Antonio Cittadini, Federico II University

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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Chronic Heart Failure Drug: Somatotropin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : January 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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
Drug: Somatotropin
Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day

No Intervention: Control CHF patients under optimized CHF therapy

Primary Outcome Measures :
  1. Peak Oxygen Consumption [ Time Frame: after 48 months ]
  2. Side effects [ Time Frame: Any side effects recorded after 6,24 and 48 months ]

Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction [ Time Frame: after 48 months ]
  2. Left Ventricular End-Systolic Volume [ Time Frame: after 48 months ]
  3. Left Ventricular End-Diastolic Volume [ Time Frame: after 48 months ]
  4. Quality of Life [ Time Frame: after 48 months ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576861

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Department of Internal Medicine, Cardiovascular and Immunological Sciences
Napoli, Campania, Italy, 80131
Sponsors and Collaborators
Federico II University
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Responsible Party: Antonio Cittadini, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT01576861    
Other Study ID Numbers: Long-Term GH in CHF
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases