NCT00591760

Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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

Conditions

• Heart Failure
• Growth Hormone Deficiency
• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Somatotropin	Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2008-01-11
• Last updated: 2012-11-19
• Results posted: 2012-11-19