NCT01687699已完成4 期
Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients
Dialysis Outcomes Heart Failure Aldactone Study Group1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- cardio- and cerebrovascular events
研究概览
简要总结
Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
- •With an average serum potassium level (immediately before dialysis on the first day of the week) of <6.5 mEq/l over the previous 2 months
- •With a 24-hour urine output of <500 ml
排除标准
- •A history of noncompliance
- •Unstable vascular access
- •Hypotension
- •Hepatic failure
- •Active cancer
- •Any life-threatening disease other than ESRD
研究组 & 干预措施
spironolactone
Experimental
干预措施: Spironolactone (Drug)
结局指标
主要结局
cardio- and cerebrovascular events
次要结局
- death from all causes
研究者
Yoshihiro Matsumoto
MD., PhD.
Dialysis Outcomes Heart Failure Aldactone Study Group
研究点 (1)
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