A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
试验速览
- 阶段
- 2 期
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death
研究概览
简要总结
This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older at randomization
- •Heart failure with at least one of the following signs of current fluid overload:
- •Peripheral (or sacral) edema >1+ or ascites during screening or on day of randomization
- •Pulmonary congestion as determined by chest X-ray during the screening period
- •Ambulatory and able to perform the 6-minute walk test
排除标准
- •Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening
- •Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening
- •Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation
- •Heart transplant recipient, or anticipated need for transplant or LVAD during study participation
- •Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator
研究组 & 干预措施
CLP
CLP BID
干预措施: CLP (Drug)
Placebo
BID powder
干预措施: placebo (Drug)
结局指标
主要结局
Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death
时间窗: Baseline, Week 8
Composite endpoint for the change from baseline to 8 weeks comprised of the following: 6-Minute Walk Test (6 MWT), Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death.
次要结局
- Change in 6-Minute Walk Test distance from baseline to Week 8.(Baseline, Week 8)
- Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death(8 weeks)