BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy (LIONHEART-HCM)
A Phase 3, Multi-region, Multi-center, Randomized, Double-blind, Active-Comparator-Controlled Trial to Evaluate the Efficacy and Safety of BHB-1893 Compared to Metoprolol in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The main purpose of this trial is to find out whether BHB-1893 works better than metoprolol in adults with symptoms of obstructive hypertrophic cardiomyopathy (oHCM). The trial includes adults who are currently being treated for oHCM or who have not yet been treated.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Study Director
- 电话号码：(415) 707-6312
- 邮箱：info@braveheart.bio
学习地点
-
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New York
-
Manhasset、New York、美国、11030
- 招聘中
- LIONHEART-HCM Site 0107
-
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South Carolina
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Rock Hill、South Carolina、美国、29732
- 招聘中
- LIONHEART-HCM Site 0126
-
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Texas
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Plano、Texas、美国、75024
- 招聘中
- LIONHEART-HCM Site 0121
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Diagnosed with oHCM per the protocol specified criteria
- NYHA Class II or III at screening visits
- KCCQ-CSS that meets the protocol specified criteria at screening visits
- Adequate acoustic windows for echocardiography
Key Exclusion Criteria:
-
Medical indication for either β-blocker or calcium-channel blocker therapy, other than oHCM, prohibiting drug discontinuation
-
History of intolerance or medical contraindication to β-blocker therapy
-
Resting systolic blood pressure (SBP) of >160 millimeters of mercury (mmHg) at screening visits
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Resting heart rate of >100 beats per minute (bpm) at screening visits
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Significant valvular heart disease, defined as:
- Moderate to severe valvular aortic stenosis or fixed subaortic obstruction;
- Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator's judgment)
Other protocol-defined criteria apply.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BHB-1893
Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily. |
Tablets for oral use |
|
有源比较器：Metoprolol
Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily. |
Capsules for oral use |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
大体时间：Baseline, Week 24
|
Baseline, Week 24
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)
大体时间：Baseline, Week 24
|
Baseline, Week 24
|
|
Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class
大体时间：Baseline to Week 24
|
Baseline to Week 24
|
|
Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
大体时间：Baseline, Week 24
|
Baseline, Week 24
|
|
Change from Baseline in Left Atrial Volume Index
大体时间：Baseline, Week 24
|
Baseline, Week 24
|
|
Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration
大体时间：Baseline, Week 24
|
Baseline, Week 24
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.