Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy (REMAP-HCM)
Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：First line of the email MUST contain NCT # and Site #.
研究联系人备份
- 姓名：BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- 电话号码：855-907-3286
- 邮箱：Clinical.Trials@bms.com
学习地点
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Shanghai、中国
- Fudan University Zhongshan Hospital
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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
取样方法
研究人群
The study will include adults in China diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) who initiated mavacamten treatment between 24 October 2024 and 31 March 2026.
描述
Inclusion Criteria:
Participants must meet all of the following criteria to be included:
- Diagnosis: Have a documented diagnosis of obstructive hypertrophic cardiomyopathy (oHCM), identified by the corresponding International Classification of Diseases (ICD)-10 codes in the medical record system.
- Medication Exposure: Have a first-ever recorded prescription for Mavacamten within the Patient Identification Period (24 October 2024 to 31 March 2026). This date is defined as the Index Date.
- Age: Be ≥ 18 years of age at the Index Date.
- Treatment Continuity: Have at least two valid clinical records of any type (e.g., outpatient visit, inpatient encounter, prescription refill, laboratory test, or echocardiogram) after the Index Date.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
(1) Prior Use of Study Drug: Have any documented history of Mavacamten use (based on medical history records, prescription records, or clinical notes) at any time prior to the Index Date.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Category A1. Sustained Monotherapy
Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up. |
As per product label |
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Category A2. Treatment Intensification
Participants who initiate mavacamten monotherapy and subsequently added one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications during follow-up. |
As per product label |
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Category B1. Stable Combination Therapy at Initiation
Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and remain on combination therapy throughout follow-up. |
As per product label |
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Category B2. Treatment Simplification
Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and subsequently discontinued all background oHCM medications, resulting in mavacamten monotherapy. |
As per product label |
|
Category C. Complex/Unclassifiable
Participants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups. |
As per product label |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of participants in each study cohort
大体时间：Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Absolute change (mmHg) from baseline in resting peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
大体时间：Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
大体时间：Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
大体时间：Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
|
|
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New York Heart Association (NYHA) functional class classification as assessed by the treating physician
大体时间：Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
大体时间：Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
大体时间：Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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Change from baseline in E/e' ratio assessed by transthoracic echocardiography
大体时间：Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Baseline and months 1, 2, 3, 6, 9, 12 and 15
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Prescribed mavacamten dose (mg)
大体时间：Day 1 and months 1, 2, 3, 6, 9, 12 and 15
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Day 1 and months 1, 2, 3, 6, 9, 12 and 15
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Prescribed mavacamten maintenance dose (mg) during follow-up
大体时间：Up to 15 months
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Up to 15 months
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Number of participants reaching mavacamten maintenance dose
大体时间：Up to 15 months
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Up to 15 months
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Number of participants whose prescribed mavacamten dose changed during the observation period
大体时间：Day 1 and and up to 15 months
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Day 1 and and up to 15 months
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Time (days) from Index Date to achieving mavacamten maintenance dose
大体时间：Day 1 and up to 15 months
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Day 1 and up to 15 months
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Number of participants that discontinued mavacamten treatment
大体时间：Up to 15 months
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Up to 15 months
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Time (days) from Index Date to mavacamten discontinuation
大体时间：Day 1 and up to 15 months
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Day 1 and up to 15 months
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Duration of mavacamten treatment during follow-up
大体时间：Day 1 and up to 15 months
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Day 1 and up to 15 months
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Prior hypertrophic cardiomyopathy (oHCM) medication drug class
大体时间：Baseline and up to 15 months
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Drug class of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
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Prior hypertrophic cardiomyopathy (oHCM) medication dose
大体时间：Baseline and up to 15 months
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Dose of background oHCM medications, including beta-blockers and calcium channel blockers |
Baseline and up to 15 months
|
合作者和调查者
调查人员
- 研究主任：Bristol-Myers Squibb、Bristol-Myers Squibb
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
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
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