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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00591760
Other study ID # GH replacement in CHF
Secondary ID
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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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


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
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