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Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00591760
First received: December 20, 2007
Last updated: October 17, 2012
Last verified: March 2009
History of Changes
  Purpose

The aim of this study is to investigate the potential benefits of the correction of growth hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure due to left ventricular systolic dysfunction.


Condition Intervention Phase
Heart Failure
Growth Hormone Deficiency
Ischemic Heart Disease
 Drug: Somatotropin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study

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 VO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    changes in peak VO2


Enrollment: 56
Study Start Date: December 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GH
Patients will receive 6 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 for 6 months
Other Names:
  • rhGH
  • Saizen
  • NutropinAq
No Intervention: Placebo
PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Detailed Description:

To date, a wide range of alterations in the GH/IGF-1 axis have been described in patients with chronic heart failure (CHF): reductions in GH levels, reductions in IGF-1 and a pattern of peripheral resistance to GH, in particular in patients with severe heart failure and cardiac cachexia. Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current guidelines(GH stimulation test).

Our study hypothesis is that correction of GH deficiency in patients with chronic heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life.

Since this was a preliminary study, no sample size calculation was performed; treatment effects from were sought in left ventricular function (as assessed by cardiac MRI), cardiopulmonary exercise performance, clinical status, vascular reactivity, biochemistry and neurohumoral markers of disease (NT-proBNP).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Failure in ew York Heart Association functional class II to IV
  • Left ventricular end diastolic diameter > 60 mm
  • Left ventricular ejection fraction < 40%
  • Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation with GHRH + Arginine < 9 ng/dl)
  • Age 18-80 years
  • Clinical stability, guideline-oriented maximal pharmacological therapy
  • Informed consent

Exclusion Criteria:

  • Active Myocarditis
  • Hypertrophic Cardiomyopathy
  • Active endocarditis
  • Active malignancy
  • End stage renal disease
  • Severe liver disease (Child B-C)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591760

Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Antonio Cittadini, MD Federico II University - Naples
Study Chair: Luigi Saccà, MD Federico II University
  More Information

No publications provided

Responsible Party: Antonio Cittadini, Federico II University
ClinicalTrials.gov Identifier: NCT00591760     History of Changes
Other Study ID Numbers: GH replacement in CHF
Study First Received: December 20, 2007
Results First Received: March 23, 2009
Last Updated: October 17, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Federico II University:
Heart Failure
Growth Hormone
Anabolism
Anabolic Deficiency
Hormone replacement

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Dwarfism, Pituitary
Heart Diseases
Heart Failure
Endocrine System Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular 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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013