Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

Federico II University

Status: Completed

Conditions: Cardiomyopathy; Ischemic Heart Disease; Heart Failure; Growth Hormone Deficiency

Study type: Observational

Funder types: Other

Identifiers

NCT00511927

GH Deficiency in CHF

Details and patient eligibility

About

Aim of this study is to define the possible detrimental effect of a lack of growth hormone, on the well-being and life expectation of patients affected by heart failure.

Full description

Growth hormone and its main effector IGF-1 have well-documented roles in the regulation of cardiac and circulatory function. Evidence suggests that GH/IGF-1 exert a beneficial effect on cardiac load, cardiac growth and remodeling, despite their hypertrophying action. Several studies in the last years have demonstrated worse cardiovascular outcomes in adult patients with GH deficiency and/or low levels of IGF-1.

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. Our study hypothesis is that an actual status of GH deficiency coexists with CHF in a large percent of patients, and that it may represent a predictor of worse functional status and possibly of a worse prognosis. Aim of this study is to explore the latter hypothesis, comparing the clinical and functional evolution of patients with CHF and GHD with that of a general CHF population.

Enrollment: 250 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Heart Failure: NYHA class II to IV, ACC/AHA stage C/D
• Left ventricular end diastolic diameter >60 mm
• Left ventricular ejection fraction < 40%
• Clinical stability, guideline-oriented top pharmacological therapy
• Informed consent

Exclusion criteria

• Active Myocarditis
• Hypertrophic Cardiomyopathy
• Active endocarditis
• Active malignancy
• End stage renal disease
• Severe liver disease (Child B-C)

Trial design

250 participants in 2 patient groups

GHD

Description:

Patients with Growth Hormone Deficiency

non-GHD

Description:

Patients with CHF, without coexisting growth hormone deficiency