Growth Hormone's Effect on the Cardiovascular System

NCT00397319

Last updated date
Study Location
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Growth Hormone DeficiencyEffects of Growth Hormone Supplementation to Adults With Growth Hormone Deficient on Metabolism and Adipose Tissue Molecular Phenotype
NCT01616095
  1. Bratislava,
  2. Bratislava,
  3. Lubochna,
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Growth Hormone DeficiencyDevelopment and Validation of a Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency
NCT03525587
  1. Modena,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Growth Hormone DeficiencyGrowth Hormone's Effect on the Cardiovascular System
NCT00397319
  1. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Growth Hormone DeficiencyEffects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)
NCT02243852
  1. Liverpool, Merseyside
  2. Liverpool, Merseyside
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Growth Hormone's Effect on the Cardiovascular System
Official Title The Role of Growth Hormone in Cardiovascular Health
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Growth Hormone Deficiency
Intervention Drug: Growth Hormone
Study Groups/Cohorts Not Provided
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Enrollment
 (submitted: November 8, 2006)
26
Original Enrollment Same as current
Actual Study Completion Date December 2006
Primary Completion Date Not Provided
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00397319
Other Study ID Numbers 050045
1422
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Vanderbilt University
Collaborators
  • Pfizer
  • National Center for Research Resources (NCRR)
Investigators
Principal Investigator:Doug Vaughan, MDVanderbilt University Medical Center
PRS Account Vanderbilt University
Verification Date July 2007