Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

Phase 2

Completed

• Conditions: Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease
• Interventions: Drug: Somatotropin

• Registration Number: NCT00591760
• Lead Sponsor: 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.

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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

• Study Start: 2004-12
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2007-12-20
• Study First Submitted QC: 2007-12-27
• Study First Posted: 2008-01-11
• Status Verified: 2009-03
• Results First Submitted: 2009-03-23
• Results First Submitted QC: 2012-10-17
• Last Update Submitted: 2012-10-17
• Results First Posted: 2012-11-19
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GH	Somatotropin	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

Primary Outcome Measures

Name	Time	Method
Peak VO2	6 months	changes in peak VO2