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Completed

NCT Number: NCT00190580

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

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.

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Key information

Conditions

Chronic Kidney Disease Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Marianna University School of Medicine

Kawasaki, Kanagawa, 216-8511, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

valsartan, dosage from 20mg to 180mg, once or twice a day plus conventional antihypertensive drugs

Other names: Diovan 40mg or Diovan 80mg

Conventional antihypertensive drugs

Drug

Conventional antihypertensive drugs including calcium channel blockers, diuretics, angiotensin converting enzyme inhibitors and/or beta-blockers

Other names: any antihypertensive drug except ARB

Primary outcomes

  1. Course of renal and cardiac function

    Time frame: every month for renal function and every year for cardiac function

Secondary outcomes

  1. Doubling of serum creatinine concentration

    Time frame: every month

  2. End-stage renal disease

    Time frame: anytime when it occurs.

  3. Myocardial infarction

    Time frame: anytime when it occurs.

  4. Coronary revascularization

    Time frame: anytime when it occurs.

  5. Stroke

    Time frame: anytime when it occurs

  6. Hospitalization for unstable angina

    Time frame: anytime when it occurs.

  7. Hospitalization for heart failure

    Time frame: anytime when it occurs.

  8. Death from cardiovascular causes

    Time frame: anytime when it occurs.

Sponsors and collaborators

Lead sponsor

KVT-Study Group

Other

Collaborators

  • Kitasato University
  • Showa University
  • St. Marianna University School of Medicine
  • Tokai University
  • Yokohama City University

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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