Efficacy of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency

Condition(s) targeted: Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease

Intervention: Somatotropin (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Federico II University

Official(s) and/or principal investigator(s):
Antonio Cittadini, MD, Principal Investigator, Affiliation: Federico II University - Naples
Luigi Saccà, MD, Study Chair, Affiliation: Federico II University

Aim of this study is to define the possible benefits of growth hormone supplementation, in patients with heart failure due to left ventricular systolic dysfunction and coexisting growth hormone deficiency.

Official title: Preliminary Study of Growth Hormone Replacement Therapy in Patients With Chronic Heart Failure and Coexisting Growth Hormone Deficiency

Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Increase of Left Ventricular Ejection Fraction

Maximal Oxygen Consumption

Secondary outcome:

Exercise Time on Cardiopulmonary testing

Increase in Insulin-like Growth Factor 1

Detailed description: A wide range of alterations in the GH/IGF-1 axis have been described to date 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 Unpublished experience of our group has led to the observation that a considerable amount of CHF-patients have a coexisting Growth Hormone Deficiency (GHD), as defined using current diagnostic criteria (GH stimulation test).

Our study hypothesis is that treatment of GH deficiency in patients with heart failure may exert a beneficial effect on their cardiac function and remodeling, performance status and quality-of-life estimators.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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)

Starting date: December 2004
Ending date: November 2007
Last updated: December 27, 2007