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The purpose of this study is to assess the effectiveness of mavacamten treatment in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in real-world clinical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Valsalva left ventricular outflow tract (LVOT) gradient | Week 48, Week 96 | |
| Change from baseline in resting valsalva left ventricular outflow tract (LVOT) gradient | Week 48, Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in New York Heart Association (NYHA) class | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 | |
| Number and proportion of participants with a resting/provoked left ventricular outflow tract (LVOT) gradient < 30/50 mmHg |
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Inclusion Criteria:
Participants aged ≥ 18 years (participants enrolled retrospectively: at the time of initial mavacamten prescription), irrespective of gender.
Participants who have initiated mavacamten (for whom enrolled retrospectively) or are scheduled to initiate mavacamten (for whom enrolled prospectively) based on clinical therapeutic needs.
Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese guidelines for diagnosis and treatment of patients with hypertrophic cardiomyopathy, i.e., satisfy criteria below:
Has documented left ventricular ejection fraction (LVEF) ≥ 55%, as measured by resting transthoracic echocardiography (TTE) in the most recent medical record within 3 months prior to enrollment.
New York Heart Association (NYHA) class II or III symptoms in the most recent medical record within 3 months prior to enrollment.
For participants enrolled retrospectively, essential baseline information* and critical data** must be traceable and available. At least one key follow-up time points*** is required for inclusion.
Note:
* Essential baseline information, including age, gender, resting or provoked LVOT peak gradient, LVEF, indices of cardiac structure (e.g., maximum LV wall thickness, atrial and ventricular chamber size and volumes), as well as systolic and diastolic function, NYHA functional class.
Critical data, including resting or provoked LVOT gradient, LVEF, cardiac structure, systolic and diastolic function, dose of mavacamten.
Key follow-up time points: including weeks 4, 8, 12, 24, 36, 48, 72 and 96.
Exclusion Criteria:
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The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy that have received mavacamten treatment in China
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0008 | Not yet recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Week 12, Week 36, Week 48, Week 72, and Week 96 |
| Number and proportion of participants achieving complete response (defined as all left ventricular outflow tract (LVOT) gradients < 30 mmHg and New York Heart Association (NYHA) Class I) | Week 12, Week 36, Week 48, Week 72, and Week 96 |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
|
| Peking University First Affiliated Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Local Institution - 0009 | Not yet recruiting | Guangzhou | Guangdong | 510080 | China |
|
| The Second Afilliated Hospital of Hebei Medical University | Recruiting | Jiazhuang | Hebei | 050000 | China |
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| Local Institution - 0003 | Not yet recruiting | Harbin | Heilongjiang | 150086 | China |
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| Local Institution - 0007 | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Suzhou Municipal Hospital | Recruiting | Suzhou | Jiangsu | 215002 | China |
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| The Second Hospital of Jilin University | Recruiting | Changchun | Jilin | 130041 | China |
|
| Local Institution - 0005 | Not yet recruiting | Dalian | Liaoning | 116011 | China |
|
| Local Institution - 0013 | Withdrawn | Xi'an | Shan3xi | 710061 | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
|
| Local Institution - 0010 | Not yet recruiting | Jinan | 250012 | China |
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| Zhongshan Hospital Fudan University | Recruiting | Shanghai | 200032 | China |
|
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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