Effects of Valsartan on Cardiovascular Events in Patients With Renal Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Cardiovascular events
研究概览
简要总结
The purpose of this study is to investigate if an angiotensin II receptor blocker, valsartan 160 mg/day is more effective to reduce the incidence of cardiovascular events as compared to 40 mg/day in patients with moderate renal dysfunction.
详细描述
It is well known that patients with renal dysfunction have a poor prognosis concerning cardiovascular diseases. That is called "cardiorenal syndrome". It was reported that valsartan was effective in reducing the urine albumin extraction rate in patients with hyper- or normotension. We hypothesized that valsartan was more effective to prevent cardiovascular events by the intermediary of improving renal function.
The primary endpoints are:
- cardiovascular events (cardiac death, non-fatal myocardial infarction, unstable angina requiring rehospitalization, congestive heart failure requiring rehospitalization, revascularization procedures including coronary angioplasty or coronary artery bypass grafting;Stroke or transient ischaemic attack, dissociation aneurysm of the aorta needing hospitalisation;Lower limbs artery obstruction needing hospitalisation .
- end-stage renal dysfunction (introduction of hemodialysis or kidney transplantation)
- 50% reduction of creatinine clearance
The secondary endpoints are:
- systolic and diastolic function of the left ventricle estimated by echocardiography (% FS and E/A ratio)
- specific biochemical markers for cardiac or renal function (urine microalbumin, plasma B-type natriuretic peptide, plasma type 1 plasminogen activator inhibitor, plasma cystatin C)
- % changes of creatinine clearance between start and end of the study period
- transition of 1/(serum Cr) in patients whose u-prot/u-Cr is equal to or more than 1.0
- transition of serum K
- HbA1c
- New onset Atrial Fibrillation
- New onset Diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Valsartan 40mg
Standard Dose valsartan
干预措施: valsartan (Drug)
Valsartan 160mg
High Dose valsartan
干预措施: valsartan (Drug)
结局指标
主要结局
Cardiovascular events
时间窗: 2 years
End-stage renal dysfunction
时间窗: 2 years
50% reduction of creatinine clearance
时间窗: 2 years
次要结局
- 1/(serum Cr)(2 years)
- U-prot/U-Cr(2 years)
- Adverse drug effects(2 years)
- % FS and E/A ratio(2 years)
- Specific biochemical markers for cardiac or renal function(6 months and 1 year and 2 years)
- % changes of creatinine clearance(2 years)
- Serum K(2 years)
- HbA1c(2 years)
- New onset Atrial Fibrillation(2 years)
研究者
Hisao Ogawa
Professor
Kumamoto University