Rosuvastatin Effect on Serial Echocardiographic Measurement of Coronary Flow Velocity Reserve
Condition: Hypertension; Cardiovascular Risk Factors
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      In ASCOT study, lipid lowering with a statin provided additional beneficial effects in
      hypertensive patients with average levels of serum total cholesterol. However, the underlying
      mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect
      of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients.
      Therefore, it is clinically important and timely project to measure CFR non-invasively using
      echocardiography and to elucidate the mechanism of clinical benefits of statins in
      hypertensive patients with cardiovascular risk. The investigators try to evaluate the effect
      of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin,
      and to correlate CFR with LDL-cholesterol and CRP.
    

Detailed description: 
      In hypertensive patients with high risk, lipid lowering with a statin provided additional
      beneficial effects in hypertensive patients with average levels of serum total cholesterol.
      However, the underlying mechanism of statins to improve clinical outcomes in hypertension is
      unclear. In patients with hypercholesterolemia or coronary atherosclerosis, several studies
      reported that level of LDL-cholesterol was inversely correlated with coronary blood flow
      reserve and suggested that statin improved coronary blood flow. Although it is speculated
      that statin may improve coronary blood flow by decreasing LDL cholesterol level and
      stabilizing atherosclerotic plaque in coronary atherosclerosis, the effect of statins on
      coronary flow reserve (CFR) has not been examined in hypertensive patients.

      LDL cholesterol is expected to significantly decrease when rosuvastatin 20mg is administered.
      In addition to LDL-cholesterol lowering effect, the stabilization of atherosclerotic plaque
      and the regression of atheroma are observed during rosuvastatin treatment. Because of these
      beneficial effects of rosuvastatin, it may be expected that rosuvastatin will improve
      coronary blood flow even in hypertensive patients without hypercholesterolemia and the
      efficacy of rosuvastatin on CFR needs to be investigated in hypertensive patients with
      cardiovascular risk.

      Morphologic assessment for the measurement of coronary lumen in the invasive coronary
      angiography is used as a gold standard to assess the stenosis in coronary diseases. However,
      as decrease of myocardial blood flow due to coronary artery disease could not be exactly
      evaluated by morphologic stenosis, the functional test was required to assess the
      significance of coronary artery stenosis, and CFR could be directly measured using Doppler
      guide wire since mid-1990s. Since the pathophysiological implication of coronary stenosis can
      be assessed using CFR measurement, CFR value is widely used in clinical practice as a very
      useful indicator to assess coronary stenosis severity in performing percutaneous coronary
      intervention. As a high frequency transducer with excellent resolution has been used,
      coronary artery can be directly imaged, and coronary flow velocity can be measured using
      echo-Doppler technique. As a result, CFR is easily measured in an echocardiography lab which
      could be measured only in a cardiac catheterization lab using Doppler guide wire in the past.
      It was confirmed that CFR values obtained by Doppler technique were same as those invasively
      obtained in a cardiac catheterization lab. The clinical usefulness and accuracy of the
      technique have been verified also in the diagnosis of coronary artery disease.

      Therefore, it is clinically important and timely project to measure CFR non-invasively using
      echocardiography and to elucidate the mechanism of clinical benefits of statins in
      hypertensive patients with cardiovascular risk. We try to evaluate the effect of rosuvastatin
      on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin, and to
      correlate CFR with LDL-cholesterol and CRP.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): After baseline assessment, the starting dose of rosuvastatin 10 mg will be given to study patients. If tolerated and LDL-C is > 100mg/dL after 2-4 weeks, the dose will be increased to 20 mg. Rosuvastatin treatment is scheduled to continue for 1 year without no further dose titration, and each patient will be followed at 2 months, 6 months and 1 year.
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Rosuvastatin; Coronary flow reserve