RecruitingNCT07361289

A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China

A Single-Arm Observational Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China


Sponsor

Bristol-Myers Squibb

Enrollment

500 participants

Start Date

Jan 15, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria7

  • 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 myectomy or percutaneous alcohol septal ablation \[ASA\] or septal radiofrequency ablation) within 6 months prior to enrollment (participants enrolled retrospectively: within 6 months prior to initial mavacamten prescription); participants with an unsuccessful myectomy or percutaneous ASA or septal radiofrequency ablation performed \>6 months prior to enrollment (participants enrolled retrospectively: within 6 months prior to initial mavacamten prescription) may be enrolled.
  • Currently treated with disopyramide or ranolazine (within 14 days prior to enrollment \[participants enrolled retrospectively: within 14 days prior to initial mavacamten prescription\]) or participants who are expected to be taking disopyramide, ranolazine, verapamil in combination with β-receptor blockers, or diltiazem in combination with β-receptor blockers during the study.
  • Presence of other diseases that may affect completion of 96 weeks follow-up as assessed by the investigator.
  • Participants who are using or are expected to be using moderate to strong CYP2C19 inhibitors/inducers, or strong CYP3A4 inhibitors, moderate to strong CYP3A4 inducers during the study.
  • Participants who are participating in other interventional clinical studies.

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Interventions

DRUGMavacamten

According to the product label


Locations(15)

Local Institution - 0008

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Peking University First Affiliated Hospital

Beijing, Beijing Municipality, China

Local Institution - 0009

Guangzhou, Guangdong, China

The Second Afilliated Hospital of Hebei Medical University

Jiazhuang, Hebei, China

Local Institution - 0003

Harbin, Heilongjiang, China

Local Institution - 0007

Zhengzhou, Henan, China

Local Institution - 0015

Suzhou, Jiangsu, China

Local Institution - 0004

Changchun, Jilin, China

Local Institution - 0005

Dalian, Liaoning, China

Local Institution - 0013

Xi'an, Shan3xi, China

Local Institution - 0012

Chengdu, Sichuan, China

Local Institution - 0006

Hangzhou, Zhejiang, China

Local Institution - 0010

Jinan, China

Local Institution - 0011

Shanghai, China

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NCT07361289


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