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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

December 20, 2007
October 17, 2012
December 2004
November 2007   (final data collection date for primary outcome measure)
Peak VO2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
changes in peak VO2
  • Increase of Left Ventricular Ejection Fraction [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Maximal Oxygen Consumption [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00591760 on ClinicalTrials.gov Archive Site
Not Provided
  • Exercise Time on Cardiopulmonary testing [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Increase in Insulin-like Growth Factor 1 [ Time Frame: 6 Months, 12 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study

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.

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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).

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Heart Failure
  • Growth Hormone Deficiency
  • Ischemic Heart Disease
Drug: Somatotropin
Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
Other Names:
  • rhGH
  • Saizen
  • NutropinAq
  • 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
    Intervention: Drug: Somatotropin
  • No Intervention: Placebo
    PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
November 2007
November 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00591760
GH replacement in CHF
No
Antonio Cittadini, Federico II University
Federico II University
Not Provided
Principal Investigator: Antonio Cittadini, MD Federico II University - Naples
Study Chair: Luigi Saccà, MD Federico II University
Federico II University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP