A Single-Arm Observational Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
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
• Participants aged ≥ 18 years (participants enrolled retrospectively: at the time of initial mavacamten prescription), irrespective of gender.
• 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 unexplained left ventricular (LV) hypertrophy with non-dilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy) in the most recent medical record within 3 months prior to enrollment, and
⁃ Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or with provocation in the most recent medical record within 3 months prior to enrollment as assessed by echocardiography.
• 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.
• Participants who have initiated mavacamten (for whom enrolled retrospectively) or are scheduled to initiate mavacamten (for whom enrolled prospectively) based on clinical therapeutic needs.
• For participants enrolled retrospectively, must have traceable essential baseline information (including age, gender, resting LVOT peak gradient, Valsalva LVOT peak gradient, LVEF, indices of cardiac structure, systolic and diastolic function, cardiac biomarkers, NYHA functional class) and critical data (including resting and Valsalva LVOT gradient, LVEF, cardiac structure, systolic and diastolic function, dose of mavacamten) at key follow-up time points that have been completed.
• Voluntary sign informed consent form.