NCT01265524已完成2 期
A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 主要终点
- Change in Serum Potassium
研究概览
简要总结
The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload 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
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 III or IV
- •Hospitalization for heart failure decompensation associated with fluid overload within the last six months
- •Chronic kidney disease
- •Must be able to understand study procedures and willing and able to provide written informed consent
排除标准
- •No hospitalization within 4 weeks of Baseline Visit
- •In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe
- •History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
- •Current dialysis patient, or anticipated need for dialysis during study participation
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo, capsules
干预措施: Placebo (Drug)
CLP
Active Comparator
Investigational drug: 15 g CLP per day given as capsules
干预措施: CLP (Drug)
结局指标
主要结局
Change in Serum Potassium
时间窗: Baseline and 8 weeks
Change in serum potassium from baseline to Week 8.
次要结局
- Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8(Baseline and 8 weeks)
- Weight Loss at Week 1(Baseline and 1 week)
- Weight Loss at Week 2(Baseline and 2 weeks)
- Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4(4 weeks)
- Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8(8 weeks)
- 6MWT Distance at Week 8(Baseline and 8 weeks)
研究者
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