NCT01598740已完成1 期
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Fecal Sodium Content
研究概览
简要总结
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Heart failure with New York Heart Association (NYHA) Classification II or III
- •Chronic kidney disease
- •Cardiac ejection fraction <40%
- •On heart failure therapy including an ACEI or ARB, and a BB
- •Willing to understand and comply with study procedures and provide written informed consent.
排除标准
- •Hospitalization within 4 weeks of baseline visit
- •History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
- •Current or anticipated dialysis during study
- •In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
- •Drug or alcohol abuse
研究组 & 干预措施
CLP with spironolactone
Experimental
干预措施: CLP (Drug)
CLP with spironolactone
Experimental
干预措施: Spironolactone (Drug)
CLP without spironolactone
Experimental
干预措施: CLP (Drug)
结局指标
主要结局
Change in Fecal Sodium Content
时间窗: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
次要结局
- Change in Fecal Weight(baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32))
研究者
研究点 (1)
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