Growth Hormone Deficiency in Chronic Heart Failure: an Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antonio Cittadini, Federico II University
ClinicalTrials.gov Identifier:
NCT00511927
First received: August 3, 2007
Last updated: February 18, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Sera of the patients at time-points upon recruitment and after 12 months


Enrollment: 250
Study Start Date: July 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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
Study Population

Patients with chronic heart failure due to left ventricular systolic dysfunction

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511927

Locations
Italy
III Medicina Interna - Federico II University
Naples, Italy, 80100
Sponsors and Collaborators
Federico II University
Investigators
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: February 18, 2014
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:
Heart Failure
Heart Diseases
Cardiomyopathies
Endocrine System Diseases
Dwarfism, Pituitary
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular 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
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014