Clinical trial NCT00190580: Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease
Official title: Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Hypertension
Keywords: CKD
chronic kidney disease
hypertension
angiotensin II receptor blocker
cardiovascular disease
valsartan
KVT
Lead sponsor: KVT-Study Group
Sponsor class: OTHER
Collaborators: name: Tokai University
name: Yokohama City University
name: Showa University
name: Kitasato University
name: St. Marianna University School of Medicine
First posted: 2005-09-19
Enrollment: 312
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Course of renal and cardiac function
timeFrame: every month for renal function and every year for cardiac function
Secondary outcomes:
measure: Doubling of serum creatinine concentration
timeFrame: every month
measure: End-stage renal disease
timeFrame: anytime when it occurs.
measure: Myocardial infarction
timeFrame: anytime when it occurs.
measure: Coronary revascularization
timeFrame: anytime when it occurs.
measure: Stroke
timeFrame: anytime when it occurs
measure: Hospitalization for unstable angina
timeFrame: anytime when it occurs.
measure: Hospitalization for heart failure
timeFrame: anytime when it occurs.
measure: Death from cardiovascular causes
timeFrame: anytime when it occurs.
Other outcomes:
Locations:
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine
state: Kanagawa
Study officials:
affiliation: St. Marianna University School of Medicine
name: Kenjiro Kimura, MD, PhD
role: STUDY_CHAIR
References: