NCT00328809撤回4 期
Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone
State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家开始时间: 2013年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- risk of hyperkalemia
研究概览
简要总结
Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They must be at least 18 years of age.
- •They must understand the study purpose and give their written informed consent.
- •They must have been stable on chronic hemodialysis for at least three months before enrollment into the study.
- •Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction.
排除标准
- •Subjects with primary operable valvular heart disease.
- •Subjects with a congenital heart disease.
- •Subjects with unstable angina.
- •Subjects with primary hepatic failure.
- •Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease).
- •Subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible.
- •Subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis.
- •Subjects with habitually difficult to control hyperkalemia (serum potassium >6.0 meq/L) in the previous month while on dialysis will be excluded.
- •The inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.
研究组 & 干预措施
Spirnolactone
Experimental
干预措施: spironolactone (Drug)
结局指标
主要结局
risk of hyperkalemia
时间窗: 6 months
次要结局
未报告次要终点
研究者
Sri Narsipur
Associate Professor of Medicine and Pediatrics
State University of New York - Upstate Medical University
研究点 (1)
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