NCT07755904尚未招募3 期
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
Braveheart Bio, Inc.0 个研究点目标入组 210 人开始时间: 2026年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
研究概览
简要总结
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Resting heart rate of >100 beats per minute (bpm) at screening visits
- •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.
研究组 & 干预措施
BHB-1893
Experimental
Participants will receive BHB-1893 twice daily and matching placebo for metoprolol once daily.
干预措施: BHB-1893 (Drug)
Metoprolol
Active Comparator
Participants will receive metoprolol once daily and matching placebo for BHB-1893 twice daily.
干预措施: Metoprolol (Drug)
结局指标
主要结局
Change from Baseline in Peak Oxygen Uptake (pVO2) by Cardiopulmonary Exercise Testing (CPET)
时间窗: Baseline, Week 24
次要结局
- Change from Baseline in Valsalva Left Ventricular Outflow Tract Gradient (LVOT-G)(Baseline, Week 24)
- Number of Participants with >=1 Class Improvement in New York Heart Association (NYHA) Class(Baseline to Week 24)
- Change from Baseline in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)(Baseline, Week 24)
- Change from Baseline in Left Atrial Volume Index(Baseline, Week 24)
- Percent Change from Baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Concentration(Baseline, Week 24)
研究者
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