Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Heart Failure Clinical Trial

Official title:

Correction of Growth Hormone Deficiency in Patients With Chronic Heart Failure: a Randomized, Controlled, Single-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591760
• Other study ID #: GH replacement in CHF
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: October 17, 2012
• Start date: December 2004
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency
• Heart Failure
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Somatotropin
Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak VO2	changes in peak VO2	6 months	No