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

K

KVT-Study Group

Status and phase

Completed
Phase 4

Conditions

Chronic Kidney Disease
Hypertension

Treatments

Drug: valsartan
Drug: Conventional antihypertensive drugs

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

312 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

312 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Conventional antihypertensive drugs
Drug: valsartan
2
Experimental group
Treatment:
Drug: Conventional antihypertensive drugs

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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