Viewing Study NCT00511927



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Study NCT ID: NCT00511927
Status: COMPLETED
Last Update Posted: 2014-02-20
First Post: 2007-08-03

Brief Title: Growth Hormone Deficiency in Chronic Heart Failure an Observational Study
Sponsor: Federico II University
Organization: Federico II University

Study Overview

Official Title: Observational Study on Prevalence and Prognostic Value of Growth Hormone Deficiency in Patients With Chronic Heart Failure
Status: COMPLETED
Status Verified Date: 2014-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 GHIGF-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 andor low levels of IGF-1

A wide range of alterations in the GHIGF-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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None