Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT00511927

Collaborator

(none)

250

Enrollment

1

Location

43.1

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Cardiomyopathy Heart Failure Growth Hormone Deficiency

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 Design

Study Type:

Observational

Actual Enrollment :

250 participants

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
GHD Patients with Growth Hormone Deficiency
non-GHD Patients with CHF, without coexisting growth hormone deficiency

Outcome Measures

Primary Outcome Measures

overall survival [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	III Medicina Interna - Federico II University	Naples		Italy	80100

Sponsors and Collaborators

Federico II University

Investigators

Study Director: Antonio Cittadini, MD, Federico II University
Study Chair: Luigi Saccà, MD, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Cittadini, Associate Professor of Internal Medicine, Federico II University

ClinicalTrials.gov Identifier:

NCT00511927

Other Study ID Numbers:

GH Deficiency in CHF

First Posted:

Aug 6, 2007

Last Update Posted:

Feb 20, 2014

Last Verified:

Feb 1, 2014

Keywords provided by Antonio Cittadini, Associate Professor of Internal Medicine, Federico II University

Additional relevant MeSH terms:

Dwarfism, Pituitary

Cardiomyopathies

Myocardial Ischemia

Coronary Artery Disease

Endocrine System Diseases

Study Results

No Results Posted as of Feb 20, 2014