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Growth Hormone's Effect on the Cardiovascular System
This study has been terminated.
( Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed. )
Study NCT00397319   Information provided by Vanderbilt University
First Received: November 8, 2006   Last Updated: July 2, 2007   History of Changes

November 8, 2006
July 2, 2007
August 2005
 
 
 
Complete list of historical versions of study NCT00397319 on ClinicalTrials.gov Archive Site
 
 
 
Growth Hormone's Effect on the Cardiovascular System
The Role of Growth Hormone in Cardiovascular Health

To evaluate specific markers of cardiovascular risk before and after growth hormone replacement therapy in a population of growth hormone deficient adults, as compared to an age, gender, and BMI-matched healthy population.

Growth hormone deficiency (GHD) is associated with increased cardiovascular morbidity and mortality. The effects of such a deficiency include decreased exercise capacity and tolerance, impaired cardiac function, a central fat redistribution, increased peripheral arterial resistance, and an unfavorable lipid profile. These effects have been found to be reversed with appropriate replacement therapy with recombinant human growth hormone. We plan to utilize several experimental systems to further investigate the role of growth hormone (GH) in maintaining cardiovascular health. In particular, we would like to further understand the interaction of GH with Plasminogen-activator-inhibitor-1 (a major activator of the fibrinolytic system) as well as the role of GH in the maintenance of vascular function.

 
Observational
Longitudinal, Case Control, Prospective Study
Growth Hormone Deficiency
Drug: Growth Hormone
 
Devin JK, Blevins LS Jr, Verity DK, Chen Q, Bloodworth JR Jr, Covington J, Vaughan DE. Markedly impaired fibrinolytic balance contributes to cardiovascular risk in adults with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Sep;92(9):3633-9. Epub 2007 Jun 19.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
26
December 2006
 

Inclusion Criteria:

  • Adult between the ages of 18 and 65
  • Documented Growth Hormone Deficiency as defined by a peak Growth Hormone during a GHRH-Arginine Stimulation test not exceeding 9.5 ng/ml

Exclusion Criteria:

  • Personal history of cardiovascular disease (previous myocardial infarction or known coronary artery disease) or diagnosis of heart disease between study visits.
  • Personal history of diabetes mellitus or development of diabetes between study visits.
  • Initiation of an anti-cholesterol medication or anti-hypertensive between baseline and follow-up study visit.
  • Initiation of regular tobacco use between baseline and follow-up study visit.
  • Pregnancy or nursing
  • Current daily use of any drug known to affect the fibrinolytic system: Aspirin, Aggrenox, Plavix, Persantine, Ticlid, Pletal, Trental, Lovenox, Coumadin, Agrylin, and Hydroxyurea.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00397319
 
050045, 1422
Vanderbilt University
  • Pfizer
  • National Center for Research Resources (NCRR)
Principal Investigator: Doug Vaughan, MD Vanderbilt University
Vanderbilt University
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP