Phase
Condition
Cardiac Disease
Cardiovascular Disease
Heart Defect
Treatment
Mavacamten
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants aged ≥ 18 years (participants enrolled retrospectively: at the time ofinitial mavacamten prescription), irrespective of gender.
Participants who have initiated mavacamten (for whom enrolled retrospectively) orare scheduled to initiate mavacamten (for whom enrolled prospectively) based onclinical therapeutic needs.
Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with currentAmerican College of Cardiology Foundation/American Heart Association, EuropeanSociety of Cardiology, and Chinese guidelines for diagnosis and treatment ofpatients with hypertrophic cardiomyopathy, i.e., satisfy criteria below:
Has a documented diagnosis of HCM prior to enrollment, and
Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or withprovocation in the most recent medical record within 3 months prior toenrollment as assessed by echocardiography.
Has documented left ventricular ejection fraction (LVEF) ≥ 55%, as measured byresting transthoracic echocardiography (TTE) in the most recent medical recordwithin 3 months prior to enrollment.
New York Heart Association (NYHA) class II or III symptoms in the most recentmedical record within 3 months prior to enrollment.
For participants enrolled retrospectively, essential baseline information* andcritical data** must be traceable and available. At least one key follow-up timepoints*** 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.
Voluntary sign informed consent form. Note: For participants enrolledretrospectively, the most recent medical record within 3 months asmentioned in the above requirements refer to the most recent medicalrecord within 3 months prior to the initial mavacamten prescription.
Exclusion
Exclusion Criteria:
Known HCM phenocopy disease (e.g., Fabry disease, amyloidosis).
Participants who are expected to undergo major cardiac surgery during the study.
Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomyor percutaneous alcohol septal ablation [ASA] or septal radiofrequency ablation)within 6 months prior to enrollment (participants enrolled retrospectively: within 6months prior to initial mavacamten prescription); participants with an unsuccessfulmyectomy or percutaneous ASA or septal radiofrequency ablation performed >6 monthsprior to enrollment (participants enrolled retrospectively: within 6 months prior toinitial mavacamten prescription) may be enrolled.
Currently treated with disopyramide or ranolazine (within 14 days prior toenrollment [participants enrolled retrospectively: within 14 days prior to initialmavacamten prescription]) or participants who are expected to be takingdisopyramide, ranolazine, verapamil in combination with β-receptor blockers, ordiltiazem in combination with β-receptor blockers during the study.
Presence of other diseases that may affect completion of 96 weeks follow-up asassessed by the investigator.
Participants who are using or are expected to be using moderate to strong CYP2C19inhibitors/inducers, or strong CYP3A4 inhibitors, moderate to strong CYP3A4 inducersduring the study.
Participants who are participating in other interventional clinical studies.
Study Design
Connect with a study center
Local Institution - 0008
Beijing, Beijing Municipality 100029
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing, Beijing Municipality 100032
ChinaActive - Recruiting
Peking University First Affiliated Hospital
Beijing, Beijing Municipality 100034
ChinaActive - Recruiting
Local Institution - 0001
Beijing 1816670, Beijing Municipality 2038349 100032
ChinaSite Not Available
Local Institution - 0002
Beijing 1816670, Beijing Municipality 2038349 100034
ChinaSite Not Available
Local Institution - 0008
Beijing 1816670, Beijing Municipality 2038349 100029
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing 1816670, Beijing Municipality 2038349 100032
ChinaSite Not Available
Local Institution - 0009
Guangzhou, Guangdong 510080
ChinaSite Not Available
Local Institution - 0009
Guangzhou 1809858, Guangdong 1809935 510080
ChinaSite Not Available
The Second Afilliated Hospital of Hebei Medical University
Jiazhuang, Hebei 050000
ChinaActive - Recruiting
Local Institution - 0014
Jiazhuang 9528222, Hebei 1808773 050000
ChinaSite Not Available
The Second Afilliated Hospital of Hebei Medical University
Jiazhuang 9528222, Hebei 1808773 050000
ChinaSite Not Available
Local Institution - 0003
Harbin, Heilongjiang 150086
ChinaSite Not Available
Local Institution - 0003
Harbin 2037013, Heilongjiang 2036965 150086
ChinaSite Not Available
Local Institution - 0007
Zhengzhou, Henan 450052
ChinaSite Not Available
Local Institution - 0007
Zhengzhou 1784658, Henan 1808520 450052
ChinaSite Not Available
Local Institution - 0015
Suzhou, Jiangsu 215002
ChinaSite Not Available
Suzhou Municipal Hospital
Suzhou, Jiangsu 215002
ChinaActive - Recruiting
Local Institution - 0015
Suzhou 1886760, Jiangsu 1806260 215002
ChinaSite Not Available
Local Institution - 0004
Changchun, Jilin 130041
ChinaSite Not Available
The Second Hospital of Jilin University
Changchun, Jilin 130041
ChinaActive - Recruiting
Local Institution - 0004
Changchun 2038180, Jilin 2036500 130041
ChinaSite Not Available
Local Institution - 0005
Dalian, Liaoning 116011
ChinaSite Not Available
Local Institution - 0005
Dalian 1814087, Liaoning 2036115 116011
ChinaSite Not Available
Local Institution - 0013
Xi'an, Shan3xi 710061
ChinaSite Not Available
Local Institution - 0013
Xi'an 1790630, Shan3xi 710061
ChinaSite Not Available
Local Institution - 0012
Chengdu, Sichuan 610041
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaActive - Recruiting
Local Institution - 0012
Chengdu 1815286, Sichuan 1794299 610041
ChinaSite Not Available
Local Institution - 0006
Hangzhou, Zhejiang 310009
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
Local Institution - 0006
Hangzhou 1808926, Zhejiang 1784764 310009
ChinaSite Not Available
Local Institution - 0010
Jinan, 250012
ChinaSite Not Available
Local Institution - 0010
Jinan 1805753, 250012
ChinaSite Not Available
Local Institution - 0011
Shanghai, 200032
ChinaSite Not Available
Zhongshan Hospital Fudan University
Shanghai, 200032
ChinaActive - Recruiting
Local Institution - 0011
Shanghai 1796236, 200032
ChinaSite Not Available

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