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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyoto Prefectural University of Medicine
• Treatments: Antihypertensive Agents; Valsartan

Criteria

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.)