NCT06516068进行中（未招募）2 期
A Multicenter, Randomized, Open-label Phase II Clinical Study on the Efficacy and Safety of HRS-1893 in Obstructive Hypertrophic Cardiomyopathy Subjects.
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年8月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver
研究概览
简要总结
The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old, gender unlimited;
- •The diagnosis was obstructive hypertrophic cardiomyopathy.
- •Echocardiographic laboratory tests showed LVEF≥60%;
- •No previous left ventricular systolic dysfunction at any time (LVEF < 45%);
- •Understand the study procedure and sign the informed consent in person, willing to strictly follow the clinical study protocol to complete the study.
排除标准
- •Known or suspected invasive, genetic or storage diseases (e.g. Noonan syndrome, Fabre's disease, amyloidosis) that cause cardiac hypertrophy (similar to oHCM);
- •Previous left ventricular systolic dysfunction at any time in the clinical course (LVEF < 45%);
- •Previous history of aortic stenosis or subaortic fixed stenosis;
研究组 & 干预措施
HRS-1893
Experimental
干预措施: HRS-1893 (Drug)
结局指标
主要结局
The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver
时间窗: After 12 weeks of HRS-1893 treatment
次要结局
- Change in NT-proBNP(Baseline to Week 12)
- Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE)(Through study completion, an average of 68 weeks)
- Change in LVEF(Baseline to Week 12)
- Change in LVOT-VTI(Baseline to Week 12)
- Change in LV-GLS(Baseline to Week 12)
- Change in cardiac troponin(Baseline to Week 12)
- plasma concentration of HRS-1893(Through study completion, an average of 68 weeks)
- Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)(Baseline to Week 12)
- Proportion of participants with ≥ 1 class improvement in NYHA Functional Class(Baseline to Week 12)
- Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2)(Baseline to Week 12)
- Change in LV-FS(Baseline to Week 12)
- Change in Rest LVOT-G(Baseline to Week 12)
- Change in Valsalva LVOT-G(Baseline to Week 12)
研究者
研究点 (1)
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