NCT07367724招募中2 期
Safety and Efficacy of Ademetionine in Patients With Obstructive Hypertrophic Cardiomyopathy: A Multicenter, Double-Blind, Randomized Controlled, Phase 2 Study
China National Center for Cardiovascular Diseases3 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年1月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Change in pVO₂ by CPET from baseline to Week 16
研究概览
简要总结
This study is a multicenter, double-blind, randomized controlled Phase 2 trial designed to evaluate the safety and efficacy of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). The study will recruit patients with oHCM who, under double-blind conditions, will be randomly assigned to either the Ademetionine group or the placebo group. Follow-up visits will be conducted every 4 weeks until 16 weeks from baseline. After 16 weeks, the study will evaluating the effect of Ademetionine on exercise capacity, heart failure symptoms, cardiac structure and function, and quality of life, as well as safety and tolerability of Ademetionine in this patient population.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for HCM.
- •Age ≥ 18 years at screening.
- •LVEF ≥ 50% at screening.
- •Echocardiography demonstrates a resting or provoked LVOTG ≥ 30 mmHg at screening.
- •NYHA Functional Class II-III at screening.
- •Able to perform CPET.
- •Patients receiving treatment with β-blockers or non-dihydropyridine calcium channel blockers should have been on a stable dose for at least 6 weeks prior to randomization and are expected to maintain the same medication during the trial. Who have previously received cardiac myosin inhibitors (e.g., Mavacamten) must discontinue the treatment for at least 8 weeks prior to randomization.
- •Willing and able to sign the informed consent form and comply with all scheduled study visits.
排除标准
- •History of severe hypersensitivity to any component of Ademetionine 1,4-Butanedisulfonate Enteric-coated Tablets.
- •History of psychiatric disorders, or current use of antidepressants such as clomipramine.
- •Planned for any surgical (including septal reduction therapy) or interventional procedure during the trial period.
- •Planned use of cardiac myosin inhibitors (e.g., Mavacamten) during the trial period.
- •Currently pregnant or planning pregnancy.
- •Currently participation in another drug or device clinical trial.
- •History of any other disease with a life expectancy of less than 1 year.
研究组 & 干预措施
Ademetionine group
Active Comparator
干预措施: Ademetionine 1,4-Butanedisulfonate (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pVO₂ by CPET from baseline to Week 16
时间窗: From enrollment to the end of treatment at 16 weeks
次要结局
- Proportion of participants with ≥1 class improvement in NYHA Functional Class from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
- Change in KCCQ-CSS from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
- Change in provoked left ventricular outflow tract gradient from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
- Change in left ventricular mass index from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
- Change in left atrial volume index from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
- Change in E/e' from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
- Change in VE/VCO₂ slope by CPET from baseline to Week 16(From enrollment to the end of treatment at 16 weeks)
研究者
研究点 (3)
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