Clinical trial NCT02144922: Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients
Official title: Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Cardiovascular Risk
Keywords: Hypertension
Statin
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2014-05-22
Enrollment: 85
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Controlled Hypertension: treated SBP\<140 mmHg and DBP\<90 mmHg
* LDL cholesterol ≥ 130mg/dL
* Patients with statin-naive state, defined as receiving no statin therapy for more than 6 months during the previous 12 months.
* Any 1 of these cardiovascular risk factors required: smoking, age over 55 (men) or 65 (women), history of cerebrovascular event, family history of early CHD before age 55, HDL cholesterol \< 40 mg/dL

Exclusion Criteria:

* A previous history of intolerance or hypersensitivity to statins
* Uncontrolled hypertension; SBP≥140 mmHg or DBP≥90 mmHg
* Previous MI or currently treated angina pectoris
* Stroke, TIA \< 3 months
* Secondary hypertension
* Fasting serum triglyceride \> 500 mg/dL
* Clinical congestive heart failure
* Uncontrolled arrhythmia
* Left ventricular hypertrophy: LV mass index \>134g/m2 (male) or \>110g/m2 (female)
* Concomitant clinically important hematological, gastrointestinal, hepatic, renal or other disease
* Pregnant or lactating women and those of child-bearing potential
* Diabetes
* Peripheral vascular disease
* Unwillingness or inability to comply with the procedures described in this protocol

Primary outcomes:
measure: change in the CFR value
timeFrame: 12 months
measure: Difference in mean CFR value
timeFrame: 12 months
Secondary outcomes:
measure: change of CRP
timeFrame: 12 months
measure: Change of LDL-cholesterol
timeFrame: 12 months
measure: Change of averaged peak diastolic velocity
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Duk-Hyun Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: