Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: JW Pharmaceutical
• Treatments: Pitavastatin

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