The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.
It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function. The primary endpoints are: * 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;Stroke or transient ischaemic attack, dissociation aneurysm of the aorta needing hospitalisation;Lower limbs artery obstruction needing hospitalisation . * end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation) * 50% reduction of creatinine clearance The secondary endpoints are: * 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 microalbumin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C) * % changes of creatinine clearance between start and end of the study period * transition of 1/(serum Cr) in patients whose u-prot/u-Cr is equal to or more than 1.0 * transition of serum K * HbA1c * New onset Atrial Fibrillation * New onset Diabetes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
valsartan 40 or 160 (80) mg per day
Department of Cardiovascular Medicine, Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan
Cardiovascular events
Time frame: 2 years
End-stage renal dysfunction
Time frame: 2 years
50% reduction of creatinine clearance
Time frame: 2 years
% FS and E/A ratio
Time frame: 2 years
Specific biochemical markers for cardiac or renal function
Time frame: 6 months and 1 year and 2 years
% changes of creatinine clearance
Time frame: 2 years
1/(serum Cr)
Time frame: 2 years
Serum K
Time frame: 2 years
HbA1c
Time frame: 2 years
U-prot/U-Cr
Time frame: 2 years
Adverse drug effects
Time frame: 2 years
New onset Atrial Fibrillation
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.