Hypertension Clinical Trial
To investigate biochemical and genetic markers of inflammation and endothelial dysfunction as determinants of hypertension.
BACKGROUND:
Hypertension affects up to 50 million Americans, and is a major risk factor for
cardiovascular disease and other health outcomes. Among Black women, hypertension is more
prevalent, less well controlled by treatment, and has more damaging health outcomes versus
Whites for reasons still unclear. While several lifestyle and dietary factors are associated
with hypertension, relevant biochemical and genetic markers remain less well studied
DESIGN NARRATIVE:
This is a nested case-control study of incident hypertension in 800 case-control pairs (400
each of white and black women, totaling 1,600 women). Data will be used from the Women's
Health Initiative Observational Study (WHI-OS), a cohort of 93,676 ethnically diverse
postmenopausal women aged 50 to 79 years with extensive clinical and questionnaire data.
Three hypotheses will be tested. First, the investigators will assess whether markers of
inflammation - C reactive protein (CRP), interleukin-6 (IL-6), IL-1-8, tumor necrosis factor
(TNF) receptor 2, soluble intercellular adhesion molecule-1 (slCAM-1), and
metalloproteinase-9 (MMP-9) - are associated with the risk of hypertension in White and
Black women. Second, they will examine six novel polymorphisms linked to the above
inflammatory biomarkers - the CRP, IL-6, IL-1-beta, TNF-a, slCAM-1, and MMP-9 genes- and two
other polymorphisms related to inflammation and the metabolic syndrome- the adiponectin and
PPAR-y2 genes - for their potentially important associations with the risk of hypertension.
Third, they will comprehensively evaluate important single-nucleotide polymorphisms in the
above genes and examine associations between common haplotypes and hypertension risk in
White and Black women, using state-of-the art genotyping technology and statistical methods.
Power is excellent; for each biochemical marker, they have 80% power to detect a trend
across quintiles for a relative risk (RR) of hypertension, comparing the fifth versus first
quintiles, of 1.49 for analyses of 800 case-control pairs and 1.74 for analyses of 400
case-control pairs. For each genetic marker, they have 80% power to detect an additive
effect of an allele for a RR of hypertension of 1.36 for 800 case-control pairs and 1.57 for
400 case-control pairs.
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Observational Model: Case Control, Time Perspective: Prospective
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