Status:
COMPLETED
Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)
Lead Sponsor:
Kyoto Prefectural University of Medicine
Conditions:
Hypertension
Ischemic Heart Disease
Eligibility:
All Genders
20-79 years
Phase:
PHASE4
Brief 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 th...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
3031 Patients enrolled
Trial Details
Trial ID
NCT00149227
Start Date
January 1 2004
End Date
January 1 2009
Last Update
December 12 2012
Active Locations (1)
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1
Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan, 602-8566