The purpose of this study is to prove the hypothesis that the progression of renal and cardiovascular disease is more efficiently prevented when the angiotensin II receptor blocker valsartan is added to conventional antihypertensive therapy.
It is widely recognized that suppression of the renin-angiotensin system ameliorates progression of chronic kidney disease (CKD) and that CKD is an important risk factor for development of cardiovascular disease. However, it has not been fully clarified if amelioration of CKD leads to the lower incidence of cardiovascular disease. The purpose of this study is to determine whether the angiotensin II receptor antagonist valsartan, in combination with conventional antihypertensive therapy, will ameliorate progression of both CKD and cardiovascular disease. The primary outcome is courses of renal and cardiac function. The secondary outcome is a composite of a doubling of serum creatinine concentration, end-stage renal disease, myocardial infarction, coronary revascularization, stroke, hospitalization for unstable angina, hospitalization for heart failure or death from cardiovascular causes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers
St. Marianna University School of Medicine
Kawasaki, Kanagawa, Japan
Course of renal and cardiac function
Time frame: every month for renal function and every year for cardiac function
Doubling of serum creatinine concentration
Time frame: every month
End-stage renal disease
Time frame: anytime when it occurs.
Myocardial infarction
Time frame: anytime when it occurs.
Coronary revascularization
Time frame: anytime when it occurs.
Stroke
Time frame: anytime when it occurs
Hospitalization for unstable angina
Time frame: anytime when it occurs.
Hospitalization for heart failure
Time frame: anytime when it occurs.
Death from cardiovascular causes
Time frame: anytime when it occurs.
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