Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

NCT ID: NCT00511927

Last Updated: 2014-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-02-28

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.

Conditions

Ischemic Heart Disease; Cardiomyopathy; Heart Failure; Growth Hormone Deficiency

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GHD

Patients with Growth Hormone Deficiency

No interventions assigned to this group

non-GHD

Patients with CHF, without coexisting growth hormone deficiency

No interventions assigned to this group

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Antonio Cittadini

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Cittadini, MD

Role: STUDY_DIRECTOR

Federico II University

Luigi Saccà, MD

Role: STUDY_CHAIR

Federico II University

Locations

III Medicina Interna - Federico II University

Naples, , Italy

Countries

Italy

Other Identifiers

GH Deficiency in CHF

Identifier Type: -

Identifier Source: org_study_id