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

Last updated: May 8, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Cardiovascular Disease

Heart Defect

Treatment

Mavacamten

Clinical Study ID

NCT07361289
CV027-1210
  • Ages > 18
  • All Genders

Study 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 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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Mavacamten
Phase:
Study Start date:
January 15, 2026
Estimated Completion Date:
August 28, 2028

Connect with a study center

  • Local Institution - 0008

    Beijing, Beijing Municipality 100029
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality 100032
    China

    Active - Recruiting

  • Peking University First Affiliated Hospital

    Beijing, Beijing Municipality 100034
    China

    Active - Recruiting

  • Local Institution - 0001

    Beijing 1816670, Beijing Municipality 2038349 100032
    China

    Site Not Available

  • Local Institution - 0002

    Beijing 1816670, Beijing Municipality 2038349 100034
    China

    Site Not Available

  • Local Institution - 0008

    Beijing 1816670, Beijing Municipality 2038349 100029
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349 100032
    China

    Site Not Available

  • Local Institution - 0009

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Local Institution - 0009

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • The Second Afilliated Hospital of Hebei Medical University

    Jiazhuang, Hebei 050000
    China

    Active - Recruiting

  • Local Institution - 0014

    Jiazhuang 9528222, Hebei 1808773 050000
    China

    Site Not Available

  • The Second Afilliated Hospital of Hebei Medical University

    Jiazhuang 9528222, Hebei 1808773 050000
    China

    Site Not Available

  • Local Institution - 0003

    Harbin, Heilongjiang 150086
    China

    Site Not Available

  • Local Institution - 0003

    Harbin 2037013, Heilongjiang 2036965 150086
    China

    Site Not Available

  • Local Institution - 0007

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Local Institution - 0007

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Site Not Available

  • Local Institution - 0015

    Suzhou, Jiangsu 215002
    China

    Site Not Available

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu 215002
    China

    Active - Recruiting

  • Local Institution - 0015

    Suzhou 1886760, Jiangsu 1806260 215002
    China

    Site Not Available

  • Local Institution - 0004

    Changchun, Jilin 130041
    China

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun, Jilin 130041
    China

    Active - Recruiting

  • Local Institution - 0004

    Changchun 2038180, Jilin 2036500 130041
    China

    Site Not Available

  • Local Institution - 0005

    Dalian, Liaoning 116011
    China

    Site Not Available

  • Local Institution - 0005

    Dalian 1814087, Liaoning 2036115 116011
    China

    Site Not Available

  • Local Institution - 0013

    Xi'an, Shan3xi 710061
    China

    Site Not Available

  • Local Institution - 0013

    Xi'an 1790630, Shan3xi 710061
    China

    Site Not Available

  • Local Institution - 0012

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Local Institution - 0012

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Site Not Available

  • Local Institution - 0006

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Local Institution - 0006

    Hangzhou 1808926, Zhejiang 1784764 310009
    China

    Site Not Available

  • Local Institution - 0010

    Jinan, 250012
    China

    Site Not Available

  • Local Institution - 0010

    Jinan 1805753, 250012
    China

    Site Not Available

  • Local Institution - 0011

    Shanghai, 200032
    China

    Site Not Available

  • Zhongshan Hospital Fudan University

    Shanghai, 200032
    China

    Active - Recruiting

  • Local Institution - 0011

    Shanghai 1796236, 200032
    China

    Site Not Available

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