Hypertension Clinical Trial
To investigate the prevalence and prognostic value of subclinical atherosclerosis in the Pittsburgh SHEP cohort and a cohort of normal controls.
BACKGROUND:
This is an ancillary study to the Systolic Hypertension in the Elderly Program (SHEP)
DESIGN NARRATIVE:
Continued annual telephone follow-up of the remaining 178 Pittsburgh SHEP participants and
168 controls will be conducted . A final clinic visit will include measures of coronary and
aortic calcification using electron beam computed tomography (CT), pulse wave velocity as a
measure of aortic stiffening and cognitive function testing. For the Pittsburgh SHEP cohort,
the antihypertensive treatment effect has been striking with event rates for the active and
placebo groups continuing to diverge beyong the end of SHEP. Successful demonstration of a
treatment effect on coronary calcium scores would be the first randomized data showing an
antihypertensive effect directly in the coronary arteries. Risk factors for coronary
calcification will be evaluated, producing data of a type not yet available in the
literature for older adults and not being collected in any other ongoing studies of the
elderly. The added measures of vascular stiffness will supplement the extensive data on
subclinical atherosclerosis already available for this cohort. The extent to which these
measures predict cardiovascular events will be evaluated. The study has been renewed through
July 2006.
Since hypertension and aging are associated with cognitive impairment and vascular dementia,
SHEP participants assigned to the placebo group are expected to have lower cognitive
function compared to those assigned to active treatment. Among both hypertensive and
normotensive groups, lower cognitive function among those with evidence of subclinical
atherosclerosis is expected.
Finally, members of the cohort who were originally normotensive at study entry are now
developing systolic hypertension. These subjects will allow a prospective evaluation of risk
factors for systolic hypertension. Continued study of this cohort into their 80s will
provide unique data on the risks and etiology of systolic hypertension, the efficacy of its
treatment and the prognostic value of a number of measures of subclinical atherosclerosis.
It is predicted that the results will be directly applicable to the largest growing segment
of the U.S. population.
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