Effects of Valsartan on the Progression of Renal and Cardiovascular Disease - Kanagawa Valsartan Trial (KVT)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Course of renal and cardiac function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD with serum creatinine more than 2.0 mg/dl
- •Blood pressure more than 130/85 mmHg
- •20 years old or above
排除标准
- •End-stage renal disease with maintenance dialysis
- •Polycystic kidney disease
- •Collagen disease
- •Malignant or accelerated hypertension
研究组 & 干预措施
1
干预措施: valsartan (Drug)
1
干预措施: Conventional antihypertensive drugs (Drug)
2
干预措施: Conventional antihypertensive drugs (Drug)
结局指标
主要结局
Course of renal and cardiac function
时间窗: every month for renal function and every year for cardiac function
次要结局
- Myocardial infarction(anytime when it occurs.)
- Death from cardiovascular causes(anytime when it occurs.)
- Doubling of serum creatinine concentration(every month)
- End-stage renal disease(anytime when it occurs.)
- Coronary revascularization(anytime when it occurs.)
- Stroke(anytime when it occurs)
- Hospitalization for unstable angina(anytime when it occurs.)
- Hospitalization for heart failure(anytime when it occurs.)
研究者
Kenjiro Kimura
Professor of St. Marianna University School of Medicine
KVT-Study Group