Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

• 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: Federico II University
• Information provided by: Federico II University

Tracking Information

• First Submitted Date: December 20, 2007
• First Posted Date: January 11, 2008
• Results First Submitted Date: March 23, 2009
• Results First Posted Date: November 19, 2012
• Last Update Posted Date: November 19, 2012
• Study Start Date: December 2004
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2012)

Peak VO2 [ Time Frame: 6 months ]

changes in peak VO2

Original Primary Outcome Measures (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 ]

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
• Official Title: 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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Heart Failure
• Growth Hormone Deficiency
• Ischemic Heart Disease

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 14, 2008): 56
• Original Actual Enrollment (submitted: December 27, 2007): 26
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00591760
• Other Study ID Numbers: GH replacement in CHF
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Antonio Cittadini, Federico II University
• Original Responsible Party: Same as current
• Current Study Sponsor: Federico II University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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