A Phase 2 Randomized, Double-Blind, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vepoloxamer Injection, 22.5% (Sodium-Free) in Ambulatory Subjects With Chronic Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
研究概览
简要总结
The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 through 74
- •Duration of documented heart failure >3 months
- •On stable concomitant medication regimen ≥4 weeks
- •Left ventricular ejection fraction ≤35%
- •Systolic blood pressure ≥90 mmHg
排除标准
- •Severe valvular stenosis or primary valvular regurgitation as the cause of heart failure
- •History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the prior 3 months
- •Estimated glomerular filtration rate ≤45 mL/min/1.73 m2
- •Acutely decompensated heart failure within 1 month prior to the screening visit
研究组 & 干预措施
Vepoloxamer - Low dose
Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours
干预措施: Vepoloxamer (Drug)
Vepoloxamer - High dose
Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours
干预措施: Vepoloxamer (Drug)
5% dextrose in water (D5W)
D5W administered intravenously over 3 hours
干预措施: 5% dextrose in water (Other)
结局指标
主要结局
Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
时间窗: Study Day 1 through Study Day 30
Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03
时间窗: Study Day 1 to Study Day 30
Number of subjects with a change in Six Minute Walk test
时间窗: Study Day 1 to Study Day 30
Number of subjects with a change in left ventricular end diastolic volume index
时间窗: Study Day 1 to Study Day 30
Number of subjects with a change in Borg dyspnea index
时间窗: Study Day 1 to Study Day 30
Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
时间窗: Study Day 1 to Study Day 30
次要结局
未报告次要终点