Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

Completed

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

• Registration Number: NCT00511927
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-08-03
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Study Start: 2010-07
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-18
• Last Update Posted: 2014-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	3 years

Trial Locations

Locations (1)

III Medicina Interna - Federico II University; 🇮🇹 Naples, Italy