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Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00591760
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
Sponsor:
Information provided by:
Federico II University

Tracking Information
First Submitted Date  ICMJE December 20, 2007
First Posted Date  ICMJE January 11, 2008
Results First Submitted Date  ICMJE March 23, 2009
Results First Posted Date  ICMJE November 19, 2012
Last Update Posted Date November 19, 2012
Study Start Date  ICMJE December 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
Peak VO2 [ Time Frame: 6 months ]
changes in peak VO2
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
  • Increase of Left Ventricular Ejection Fraction [ Time Frame: 6 months, 12 months ]
  • Maximal Oxygen Consumption [ Time Frame: 6 months, 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2007)
  • Exercise Time on Cardiopulmonary testing [ Time Frame: 6 months, 12 months ]
  • Increase in Insulin-like Growth Factor 1 [ Time Frame: 6 Months, 12 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Official Title  ICMJE Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
Brief Summary 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.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Growth Hormone Deficiency
  • Ischemic Heart Disease
Intervention  ICMJE Drug: Somatotropin
Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
Other Names:
  • rhGH
  • Saizen
  • NutropinAq
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2008)
56
Original Actual Enrollment  ICMJE
 (submitted: December 27, 2007)
26
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00591760
Other Study ID Numbers  ICMJE GH replacement in CHF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Antonio Cittadini, Federico II University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Federico II University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Cittadini, MD Federico II University - Naples
Study Chair: Luigi Saccà, MD Federico II University
PRS Account Federico II University
Verification Date March 2009

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