Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Rosuvastatin; Life style modification
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment