Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study
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.
Ischemic Heart Disease
Growth Hormone Deficiency
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Study on Prevalence and Prognostic Value of Growth Hormone Deficiency in Patients With Chronic Heart Failure|
- overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Sera of the patients at time-points upon recruitment and after 12 months
|Study Start Date:||July 2010|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Patients with Growth Hormone Deficiency
Patients with CHF, without coexisting growth hormone deficiency
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511927
|III Medicina Interna - Federico II University|
|Naples, Italy, 80100|
|Study Director:||Antonio Cittadini, MD||Federico II University|
|Study Chair:||Luigi Saccà, MD||Federico II University|