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Completed

NCT Number: NCT00511927

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2007
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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