The purpose of this study is to investigate if an angiotensin II receptor blocker valsartan is effective to reduce the incidence of cardiovascular events in patients with moderate renal dysfunction.

Condition	Intervention	Phase
Hypertension Renal Dysfunction	Drug: valsartan 40, 80, 160 mg per day	Phase IV

Further Study Details: 

Primary Outcomes: 50% or more than 25 ml/min reduction of creatinine clearance; end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)
Secondary Outcomes: cardiovascular events (cardiac death, non-fatal myocardial infarction, unstable angina requiring rehospitalization, congestive heart failure requiring rehospitalization); revascularization procedures including coronary angioplasty or coronary artery bypass grafting; systolic and diastolic function of the left ventricle estimated by echocardiography (%FS and E/A ratio); specific biochemical markers for cardiac or renal function (urine microalbmin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)
Expected Total Enrollment:  1056

It is well known that patients with renal dysfunction have poor prognosis concerning cardiovascular diseases. That is called “cardiorenal syndrome”. It was reported that valsartan was effective in reducing urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was effective to prevent cardiovascular events by the intermediary of improving renal function.

The primary endpoint is

• 50% or more than 25 ml/min reduction of creatinine clearance
• end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)

The secondary endpoint is

• cardiovascular events (cardiac death, non-fatal myocardial infarction, unstable angina requiring rehospitalization, congestive heart failure requiring rehospitalization)
• revascularization procedures including coronary angioplasty or coronary artery bypass grafting
• systolic and diastolic function of the left ventricle estimated by echocardiography (%FS and E/A ratio)
• specific biochemical markers for cardiac or renal function (urine microalbmin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)

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

Criteria

Inclusion Criteria:

• SBP>/=140 and/or DBP>/=90 (untreated hypertension cases)
• SBP>/=130 and/or DBP>/=80 (treated hypertension cases)
• Patients underwent coronary angiography
• Creatinine clearance between 45.0 and 59.9 ml/min

Exclusion Criteria:

• Patients treated with any angiotensin II receptor blockers
• History of allergy to valsartan
• Pregnant women
• Patients treated with drug-eluting stents

Please refer to this study by ClinicalTrials.gov identifier  NCT00140790

Tomohiro Sakamoto, MD, PhD      +81-96-373-5175    tom@kumamoto-u.ac.jp

Japan
      Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto,  860-8556,  Japan

Study chairs or principal investigators

Hisao Ogawa, MD, PhD,  Study Chair,  Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University   

Study ID Numbers:  CVM-RCT-2005-02
Last Updated:  September 2, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00140790
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-06