• new onset or recurrence of stroke
  
• new onset or recurrence of transient ischemic attack
  
• new onset or recurrence of acute myocardial infarction
  
• hospitalization due to the new onset, recurrence or worsening of heart failure and additional concomitant use of other anti-heart failure agents or increase of dosage
  
• hospitalization due to the new onset, occurrence or worsening of angina pectoris and additional concomitant use of other anti-anginal agents or increase of dosage
  
• operation of PCI or bypass operation
  
• new onset of acute dissecting aneurysm of the aorta
  
• new onset, recurrence or worsening of arteriosclerosis obliterans
  
• transition to dialysis, doubling of plasma Cr levels
  

• all cause mortality
  
• worsening of cardiac function
  
• new onset or worsening of arrhythmias
  
• new onset or worsening of diabetes mellitus or IGT
  
• uncontrolled blood pressure, etc.
  

Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.