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

This study has been completed.
Information provided by (Responsible Party):
Antonio Cittadini, Federico II University Identifier:
First received: March 19, 2012
Last updated: October 17, 2012
Last verified: October 2012
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 Intervention Phase
Growth Hormone Deficiency Chronic Heart Failure Drug: Somatotropin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Antonio Cittadini, Federico II University:

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

Secondary Outcome Measures:
  • Left Ventricular Ejection Fraction [ Time Frame: after 48 months ]
  • Left Ventricular End-Systolic Volume [ Time Frame: after 48 months ]
  • Left Ventricular End-Diastolic Volume [ Time Frame: after 48 months ]
  • Quality of Life [ Time Frame: after 48 months ]

Enrollment: 28
Study Start Date: January 2007
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01576861

Department of Internal Medicine, Cardiovascular and Immunological Sciences
Napoli, Campania, Italy, 80131
Sponsors and Collaborators
Federico II University
  More Information

Additional Information:
Responsible Party: Antonio Cittadini, Associate Professor, Federico II University Identifier: NCT01576861     History of Changes
Other Study ID Numbers: Long-Term GH in CHF
Study First Received: March 19, 2012
Last Updated: October 17, 2012

Additional relevant MeSH terms:
Heart Failure
Dwarfism, Pituitary
Heart Diseases
Cardiovascular Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 19, 2017