Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|
|
Ischemic Heart Disease Cardiomyopathy Heart Failure Growth Hormone Deficiency |
| Study Type: | Observational |
| Study Design: | 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 |
Sera of the patients at time-points upon recruitment and after 12 months
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2012 |
| Groups/Cohorts |
|---|
|
GHD
Patients with Growth Hormone Deficiency
|
|
non-GHD
Patients with CHF, without coexisting 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with chronic heart failure due to left ventricular systolic dysfunction
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| Italy | |
| III Medicina Interna - Federico II University | |
| Naples, Italy, 80100 | |
| Study Director: | Antonio Cittadini, MD | Federico II University |
| Study Chair: | Luigi Saccà, MD | Federico II University |
More Information
No publications provided
| Responsible Party: | Antonio Cittadini, Associate Professor of Internal Medicine, Federico II University |
| ClinicalTrials.gov Identifier: | NCT00511927 History of Changes |
| Other Study ID Numbers: | GH Deficiency in CHF |
| Study First Received: | August 3, 2007 |
| Last Updated: | November 17, 2012 |
| Health Authority: | Italy: Ethics Committee Italy: Ministry of Health |
Keywords provided by Federico II University:
|
heart failure growth hormone |
igf dilative cardiomyopathy |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Dwarfism, Pituitary Heart Diseases Heart Failure Endocrine System Diseases Cardiomyopathies Coronary Disease Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Dwarfism Bone Diseases, Developmental |
Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013