NCT07846176尚未招募不适用
Comprehensive Aficamten Management and Patient-reported Health Outcomes in Real-world nHCM
Second Affiliated Hospital, Zhejiang University, School of Medicine0 个研究点目标入组 100 人开始时间: 2027年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS
研究概览
简要总结
This multicenter, prospective, observational, real-world clinical study aims to evaluate the efficacy and safety of Aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) by prospectively observing changes in symptoms, biomarkers, imaging findings, and adverse reactions, etc. It will also record the dosing regimens at which individual patients achieve steady state, and explore the treatment patterns of Aficamten in Chinese patients with symptomatic nHCM.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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.
- •Confirmed diagnosis of HCM:
- •Left ventricular wall thickness ≥15 mm at any site on echocardiography or cardiac magnetic resonance.
- •Left ventricular wall thickness ≥13 mm in individuals testing positive for a pathogenic variant or in genetically affected family members.
- •Ventricular wall thickening caused by other cardiovascular diseases or systemic or metabolic disorders has been excluded.
- •Symptomatic nHCM patients meeting all of the following conditions:
- •Left ventricular outflow tract gradient (LVOTG) <30 mmHg at rest and/or with provocation.
- •Presence of any one of the following symptoms: fatigue (weakness), dyspnea, chest pain, palpitations, or syncope.
- •New York Heart Association (NYHA) functional class II or III.
- •Left ventricular ejection fraction (LVEF) ≥60% as assessed by transthoracic echocardiography.
- •Signed and dated written informed consent, and willingness to return for clinical follow-up.
排除标准
- •LVOTG ≥30 mmHg at rest and/or with provocation.
- •LVEF <50% on transthoracic echocardiography.
- •Symptomatic hypotension or systolic blood pressure (SBP) <100 mmHg.
- •Severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or currently receiving blood purification therapy.
- •Planned implantable cardioverter-defibrillator (ICD) implantation or cardiac resynchronization therapy (CRT) within 3 months.
- •Women who are pregnant or planning to become pregnant during the trial.
- •Currently participating in another investigational device or drug trial.
- •Any other clinical condition with an expected survival of less than 2 years.
研究组 & 干预措施
Aficamten group
Patients with non-obstructive hypertrophic cardiomyopathy (nHCM) receiving aficamten therapy
干预措施: receiving aficamten (Drug)
结局指标
主要结局
Percentage change from baseline in NT-proBNP and/or absolute change from baseline in KCCQ-CSS
时间窗: From enrollment to the end of treatment at 24 months
次要结局
- Absolute change from baseline in NT-proBNP(From enrollment to the end of treatment at 24 months)
- Percentage change from baseline in TnT/TnI(From enrollment to the end of treatment at 24 months)
- Absolute change from baseline in TnT/TnI(From enrollment to the end of treatment at 24 months)
- Absolute change from baseline in maximal wall thickness (MWT)(From enrollment to the end of treatment at 24 months)
- Absolute change from baseline in E/e'(From enrollment to the end of treatment at 24 months)
- Absolute change from baseline in left ventricular end-diastolic volume index (LVEDdi)(From enrollment to the end of treatment at 24 months)
- Proportion of patients with improvement of ≥1 NYHA functional class(From enrollment to the end of treatment at 24 months)
研究者
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