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Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

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ClinicalTrials.gov Identifier: NCT00591760
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : November 19, 2012
Last Update Posted : November 19, 2012
Information provided by:
Federico II University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Growth Hormone Deficiency Ischemic Heart Disease Drug: Somatotropin Phase 2

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study
Study Start Date : December 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Peak VO2 [ Time Frame: 6 months ]
    changes in peak VO2

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591760

Sponsors and Collaborators
Federico II University
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Principal Investigator: Antonio Cittadini, MD Federico II University - Naples
Study Chair: Luigi Saccà, MD Federico II University
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Responsible Party: Antonio Cittadini, Federico II University
ClinicalTrials.gov Identifier: NCT00591760    
Other Study ID Numbers: GH replacement in CHF
First Posted: January 11, 2008    Key Record Dates
Results First Posted: November 19, 2012
Last Update Posted: November 19, 2012
Last Verified: March 2009
Keywords provided by Federico II University:
Heart Failure
Growth Hormone
Anabolic Deficiency
Hormone replacement
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Endocrine System Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases