Kanagawa Valsartan Trial (KVT): Effects of Valsartan on Renal and Cardiovascular Disease
Information source: KVT-Study Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; Hypertension
Intervention: valsartan (Drug); Conventional antihypertensive drugs (Drug)
Phase: Phase 4
Status: Completed
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
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.
Clinical Details
Official title: Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Course of renal and cardiac function
Secondary outcome: Doubling of serum creatinine concentrationEnd-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.
Eligibility
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
Locations and Contacts
St. Marianna University School of Medicine, Kawasaki, Kanagawa 216-8511, Japan
Additional Information
Starting date: February 2003
Last updated: March 30, 2015
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