NCT02482207

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

A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

Statin therapy improves coronary flow reserve (CFR) and decreases cardiac morbidity and mortality in patients with coronary artery disease (CAD) and hypercholesterolemia via pleiotropic effects of statins, including regression of atheroma, stabilization of atherosclerotic plaques. Lipid lowering with a statin also provided beneficial effects in hypertensive patients with average levels of serum total cholesterol in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA). Improvements in endothelial dysfunction and CFR may be related to the beneficial effects of statins in hypertensive patients without hypercholesterolemia. Previously CFR could be invasively measured using a Doppler guide wire in a cardiac catheterization laboratory, but recent advances in echocardiographic imaging techniques have made it feasible to measure CFR noninvasively in patients without CAD, which highly correlates with the CFR measured by invasive means.Accordingly, investigators recently demonstrated that 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 and also found a weak correlation between the change of CFR and the change of LDL cholesterol in the RESERVE (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, this trial could not include placebo-control group due to the limited study budget. Although CFR was measured by blinded, batch reading of stored echocardiographic images, bias in measurement might affect the result. In our previous study, study patients continued taking their antihypertensive medications and were educated to follow lifestyle modification during the study period, which may have influenced the change in CFR during follow-up, and 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. Investigators hypothesize that rosuvastatin added to lifestyle modification will be superior to lifestyle modification alone in improving CFR in controlled hypertensive patients with cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized comparison study using echocardiography.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Rosuvastatin
BEHAVIORAL	Life style modification

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-11-26
• Completion: 2019-11-26
• First posted: 2015-06-26
• Last updated: 2021-01-13

Locations

1 site across 1 country: South Korea