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Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00511927
Enrollment
250
Registered
2007-08-06
Start date
2010-07-31
Completion date
2014-02-28
Last updated
2014-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

heart, failure, growth, hormone, igf, dilative, cardiomyopathy

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.

Interventions

None listed

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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)

Design outcomes

Primary

MeasureTime frame
overall survival3 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026