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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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576861

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

Additional Information:
preliminary short term data  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Antonio Cittadini, Associate Professor, Federico II University
ClinicalTrials.gov 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
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Dwarfism, Pituitary
Heart Failure
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Diseases
Cardiovascular Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013