Genetics of Cardiovascular Reactivity in Black Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00064675
First received: July 10, 2003
Last updated: April 4, 2013
Last verified: April 2013

July 10, 2003
April 4, 2013
July 2003
June 2008   (final data collection date for primary outcome measure)
genes associated with hyperreactivity [ Time Frame: done ] [ Designated as safety issue: No ]
several genes associated with reactivity
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Complete list of historical versions of study NCT00064675 on ClinicalTrials.gov Archive Site
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Genetics of Cardiovascular Reactivity in Black Youth
Genetics of Cardiovascular Reactivity in Black Youth

To evaluate individual differences in cardiovascular responses to acute stress in Black adolescents.

BACKGROUND:

The prevalence and severity of essential hypertension (EH) are greater among Black Americans than other ethnic groups in the U.S. Blacks are at increased risk for target organ damage from elevated blood pressure, including heart disease, stroke, and endstage renal failure. There are significant ethnic differences in cardiovascular reactivity (CVR) to stress, which is a risk factor for elevated blood pressure. Studies have shown that CVR to stress is stable over time, heritable, and predictive of future elevations in blood pressure and the development of essential hypertension. These properties make measures of CVR a valuable intermediate for genetic studies of hypertensive risk.

DESIGN NARRATIVE:

The genetic epidemiology study will test the hypothesis that individual differences in CVR to acute stress in Black youth are associated with well defined polymorphisms in candidate genes related to blood pressure including: 1) alpha- and beta-adrenergic receptor genes; 2) genes involved in catecholamine metabolism; 3) genes involved in endocrine function; 4) genes involved in the renin angiotensin system. By focusing on normotensive youth at risk for developing essential hypertension, the investigators hope to identify genes associated with the onset, rather than the sequelae, of hypertension. Moreover, given that CVR to acute stress is defined as a change in cardiovascular function evoked by an environmental manipulation of stress, the research is inherently a study of gene-environment interactions.

A total of 500 unrelated Black adolescents and young adults (equal numbers of males and females), 15-21 years of age will be studied. Buccal cell samples will be collected for DNA extraction from all subjects for genetic association analyses. Impedance cardiography and blood pressure monitoring will be used to assess components of CVR to stress during video game, mental arithmetic, cold pressor, and whole body cold exposure tasks, all of which have been utilized or developed in the laboratory. Various methods will be used to evaluate genetic associations with CVR to acute stress, including analyses of single nucleotide polymorphisms and haplotypes. Supplementary analyses will evaluate potential gene-gene interactions and additional gene-environment interactions involving chronic environmental stress.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

buccal specimens stored at Med Coll Wisconsin

Non-Probability Sample

500 African American youth

  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
June 2008
June 2008   (final data collection date for primary outcome measure)

African American non-hypertensive, no chronic disease which would affect blood pressure

Both
15 Years to 21 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00064675
1229, R01HL072375, R01HL068971-04
Not Provided
University of Tennessee
University of Tennessee
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Bruce Alpert University of Tennessee Health Science Center
University of Tennessee
April 2013

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