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

Condition(s) targeted: Chronic Kidney Disease; Hypertension

Intervention: conventional therapy plus valsartan (Drug); conventional therapy (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: KVT-Study Group

Official(s) and/or principal investigator(s):
Kenjiro Kimura, MD, PhD, Study Chair, Affiliation: St. Marianna University School of Medicine

Overall contact:
Kenjiro Kimura, MD, PhD, Phone: +44-977-8111, Ext: 3300, Email: kimura@marianna-u.ac.jp

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Course of renal and cardiac function

Secondary outcome:

Doubling of serum creatinine concentration

End-stage renal disease

Myocardial infarction

Coronary revascularization

Stroke

Hospitalization for unstable angina

Hospitalization for heart failure

Death from cardiovascular causes

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Kenjiro Kimura, MD, PhD, Phone: +44-977-8111, Ext: 3300, Email: kimura@marianna-u.ac.jp

St. Marianna University School of Medicine, Kawasaki, Kanagawa 216-8511, Japan; Recruiting
Kenjiro Kimura, MD, PhD, Principal Investigator

Starting date: February 2003
Ending date: April 2008
Last updated: April 4, 2007