Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)

Add-on Effects of Valsartan on Morbi- Mortality in High Risk Hypertension

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 in Japan with hypertension in terms of the morbidity and mortality.

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.

Inclusion Criteria:

• Clinical diagnosis of hypertension
• Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH)

Exclusion Criteria:

• Patients who have already been administered ARB
• Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)
• Severe/malignant/secondary hypertensive patients
• Pregnant women and women of childbearing potential
• History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months
• Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block
• Severe renal impairment (Serum creatinine >3.0 mg/dl)
• Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)