Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)

Conditions
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Chronic Kidney Disease, Hypertension

Intervention / Treatment
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* Drug: valsartan
* Drug: Conventional antihypertensive drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CKD with serum creatinine more than 2.0 mg/dl Blood pressure more than 130/85 mmHg 20 years old or above Exclusion Criteria: End-stage renal disease with maintenance dialysis Polycystic kidney disease Collagen disease Malignant or accelerated hypertension

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: valsartan<br>* valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs<br>* Other names: Diovan 40mg or Diovan 80mg;Drug: Conventional antihypertensive drugs<br>* Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers<br>* Other names: any antihypertensive drug except ARB;|
| Experimental: 2<br> | Drug: Conventional antihypertensive drugs<br>* Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers<br>* Other names: any antihypertensive drug except ARB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of renal and cardiac function |  | every month for renal function and every year for cardiac function | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doubling of serum creatinine concentration |  | every month | 
| End-stage renal disease |  | anytime when it occurs. | 
| Myocardial infarction |  | anytime when it occurs. | 
| Coronary revascularization |  | anytime when it occurs. | 
| Stroke |  | anytime when it occurs | 
| Hospitalization for unstable angina |  | anytime when it occurs. | 
| Hospitalization for heart failure |  | anytime when it occurs. | 
| Death from cardiovascular causes |  | anytime when it occurs. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, chronic kidney disease, hypertension, angiotensin II receptor blocker, cardiovascular disease, valsartan, KVT