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

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Hypertension
• Interventions: Drug: valsartan; Drug: Conventional antihypertensive drugs

• Registration Number: NCT00190580
• Lead Sponsor: KVT-Study Group

Brief Summary

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

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 Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-03
• Last Update Submitted: 2015-03-30
• Last Update Posted: 2015-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Conventional antihypertensive drugs	-
2	Conventional antihypertensive drugs	-
1	valsartan	-

Primary Outcome Measures

Name	Time	Method
Course of renal and cardiac function	every month for renal function and every year for cardiac function

Secondary Outcome Measures

Name	Time	Method
Death from cardiovascular causes	anytime when it occurs.
Myocardial infarction	anytime when it occurs.
Doubling of serum creatinine concentration	every month
End-stage renal disease	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.

Trial Locations

Locations (1)

St. Marianna University School of Medicine; 🇯🇵 Kawasaki, Kanagawa, Japan