Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511927
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : February 20, 2014
Information provided by (Responsible Party):
Antonio Cittadini, Federico II University

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
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 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 : July 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Patients with Growth Hormone Deficiency
Patients with CHF, without coexisting growth hormone deficiency

Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
Sera of the patients at time-points upon recruitment and after 12 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511927

III Medicina Interna - Federico II University
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
Study Director: Antonio Cittadini, MD Federico II University
Study Chair: Luigi Saccà, MD Federico II University

Responsible Party: Antonio Cittadini, Associate Professor of Internal Medicine, Federico II University Identifier: NCT00511927     History of Changes
Other Study ID Numbers: GH Deficiency in CHF
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Antonio Cittadini, Federico II University:

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Endocrine System Diseases
Dwarfism, Pituitary
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs