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.

Condition	Intervention	Phase
Hypertension Ischemic Heart Disease Congestive Heart Failure Stroke	Drug: Valsartan	Phase IV

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: 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.
Expected Total Enrollment:  3000

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.

Ages Eligible for Study:  20 Years   -   79 Years,  Genders Eligible for Study:  Both

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.)

Please refer to this study by ClinicalTrials.gov identifier  NCT00149227

Takahisa Sawada, MD,PhD      +81-75-251-5511    tsawada@koto.kpu-m.ac.jp
Hiroaki Matsubara, MD,PhD      +81-75-251-5511    matsubah@koto.kpu-m.ac.jp

Japan
      Kyoto Prefectural University of Medicine, Kyoto,  602-8566,  Japan; Recruiting

Study chairs or principal investigators

Hiroaki Matsubara, MD,PhD,  Study Chair,  Kyoto Prefectural University of Medicine   

Study ID Numbers:  KHS2004
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149227
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13