Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

Heart Failure Clinical Trial

Official title:

Observational Study on Prevalence and Prognostic Value of Growth Hormone Deficiency in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511927
• Other study ID #: GH Deficiency in CHF
• Status: Completed
• Phase: N/A
• First received: August 3, 2007
• Last updated: February 18, 2014
• Start date: July 2010
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Coronary Artery Disease
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency
• Heart Failure
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	III Medicina Interna - Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years	No