Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial

NCT ID: NCT00591760

Last Updated: 2012-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2007-11-30

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 Unpublished experience of our group support the concept that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), defined by current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

Conditions

Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease

Keywords

Heart Failure; Growth Hormone; Anabolism; Anabolic Deficiency; Hormone replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Somatotropin

Intervention Type: DRUG

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

Placebo

PLacebo will be admistred with the same devices of GH, also on top of Optimal CHF treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Somatotropin

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

Intervention Type: DRUG

Other Intervention Names

rhGH; Saizen; NutropinAq

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Federico II University

Principal Investigators

Antonio Cittadini, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University - Naples

Luigi Saccà, MD

Role: STUDY_CHAIR

Federico II University

Other Identifiers

GH replacement in CHF

Identifier Type: -

Identifier Source: org_study_id