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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190580
• Other study ID #: 620
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2005
• Last updated: March 30, 2015
• Start date: February 2003
• Est. completion date: April 2008

Study information

• Verified date: March 2009
• Source: KVT-Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• valsartan
valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs
• Conventional antihypertensive drugs
Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers

Locations

Country	Name	City	State
Japan	St. Marianna University School of Medicine	Kawasaki	Kanagawa

Sponsors (6)

Lead Sponsor	Collaborator
KVT-Study Group	Kitasato University, Showa University, St. Marianna University School of Medicine, Tokai University, Yokohama City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of renal and cardiac function		every month for renal function and every year for cardiac function	Yes
Secondary	Doubling of serum creatinine concentration		every month	Yes
Secondary	End-stage renal disease		anytime when it occurs.	Yes
Secondary	Myocardial infarction		anytime when it occurs.	Yes
Secondary	Coronary revascularization		anytime when it occurs.	Yes
Secondary	Stroke		anytime when it occurs	Yes
Secondary	Hospitalization for unstable angina		anytime when it occurs.	Yes
Secondary	Hospitalization for heart failure		anytime when it occurs.	Yes
Secondary	Death from cardiovascular causes		anytime when it occurs.	Yes