Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk

• Status: Completed
• Trial end date: 2019-11-26
• Target enrollment: 0
• Participant gender: All

Summary

Investigators recently demonstrated that coronary flow reserve (CFR) significantly improved after rosuvastatin therapy in hypertensive patients with average levels of serum cholesterol by measuring the change in CFR after 1 year treatment with rosuvastatin in the RESERVE (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, the absence of a placebo group made it difficult to exclude the possibility that lifestyle modification and antihypertensive medication also played a role in improving CFR in our previous study. In a double-blind, randomized trial, investigators try to examine the hypothesis that rosuvastatin added to lifestyle modification will be superior to lifestyle modification alone in improving CFR in hypertensive patients .

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Dong-A ST Co., Ltd.
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Controlled Hypertension: treated SBP<140 mmHg and DBP<90 mmHg with angiotensin receptor blocker (ACE inhibitor) and/or calcium channel blocker 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 coronary heart disease before age 55, HDL cholesterol < 40 mg/dL

• The patient agrees to the study protocol and the schedule of clinical and echocardiographic follow-up, and provides informed, written consent, as approved by the Institutional Review Board

Exclusion Criteria:

• A previous history of intolerance or hypersensitivity to statins

• Uncontrolled hypertension; SBP≥140 mmHg or DBP≥90 mmHg

• Previous myocardial infarction or currently treated angina pectoris

• Stroke, transient ischemic attack < 3 months

• Secondary hypertension

• Diabetes mellitus

• Peripheral vascular disease

• 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

• Unwillingness or inability to comply with the procedures described in this protocol