Hypertension Clinical Trial
Official title:
Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
Although statins reduce cardiac events in hypertensive patients with cardiovascular risk factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such patients. The investigators hypothesize that pitavastatin added to standard antihypertensive therapy will be superior to placebo in improving CFR in hypertensive patients with cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized comparison study using Doppler echocardiography.
Statin treatment improves coronary flow reserve (CFR) and decreases cardiac morbidity and
mortality in patients with coronary artery disease (CAD) and hypercholesterolemia.
Endothelial dysfunction and impairment in coronary microcirculation is also observed in
hypertensive patients with cardiovascular risk factors. However, the measurement of CFR has
rarely been performed in hypertensive patients without CAD, because CFR could be invasively
measured using a Doppler guide wire in a cardiac catheterization laboratory. Recent advances
in echocardiographic imaging techniques have made it possible to measure coronary flow
velocity and CFR, which highly correlates with the CFR measured by invasive means.
Lipid lowering with a statin provided beneficial effects in patients with average levels of
serum total cholesterol in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm
(ASCOT-LLA) study conducted in hypertensive patients at cardiovascular risk. Improvements in
endothelial dysfunction and CFR may be related to the beneficial effects of statins in
hypertensive patients without hypercholesterolemia, but the effect of statins on CFR has not
been examined in such patients. Accordingly, the investigators try to examine the hypothesis
that pitavastatin added to standard antihypertensive therapy in hypertensive patients with
cardiovascular risk will be superior to placebo in improving CFR in a double-blind,
randomized comparison study using Doppler echocardiography.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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