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

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

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Drug: Mavacamten

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• China
  • Jinan, China, 250012
    • Not yet recruiting
    • Local Institution - 0010
    • Contact: Site 0010
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan Hospital Fudan University
    • Contact: Shuning Zhang, Site 0011; Phone Number: +86 15921766132
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100032
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Zhuang Tian, Site 0001
    • Beijing, Beijing Municipality, China, 100029
      • Not yet recruiting
      • Local Institution - 0008
      • Contact: Site 0008
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Affiliated Hospital
      • Contact: Ma Wei, Site 0002; Phone Number: 86-13681050902
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Not yet recruiting
      • Local Institution - 0009
      • Contact: Site 0009
  • Hebei
    • Jiazhuang, Hebei, China, 050000
      • Recruiting
      • The Second Afilliated Hospital of Hebei Medical University
      • Contact: Xinshun Gu, Site 0014; Phone Number: +86 13930139688
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150086
      • Not yet recruiting
      • Local Institution - 0003
      • Contact: Site 0003
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Not yet recruiting
      • Local Institution - 0007
      • Contact: Site 0007
  • Jiangsu
    • Suzhou, Jiangsu, China, 215002
      • Recruiting
      • Suzhou Municipal Hospital
      • Contact: Yan Chen, Site 0015; Phone Number: +86 18015571559
  • Jilin
    • Changchun, Jilin, China, 130041
      • Recruiting
      • The Second Hospital of Jilin University
      • Contact: Bin Liu, Site 0004; Phone Number: +86043188796598
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Not yet recruiting
      • Local Institution - 0005
      • Contact: Site 0005
  • Shan3xi
    • Xi'an, Shan3xi, China, 710061
      • Not yet recruiting
      • Local Institution - 0013
      • Contact: Site 0013
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Yucheng Chen, Site 0012; Phone Number: +86 18980602149
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Xiaojie Xie, Site 0006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy that have received mavacamten treatment in China

Description

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 a documented diagnosis of HCM 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.
• 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.

    • Voluntary sign informed consent form. Note: For participants enrolled retrospectively, the most recent medical record within 3 months as mentioned in the above requirements refer to the most recent medical record within 3 months prior to the initial mavacamten prescription.

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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten	Drug: Mavacamten; According to the product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): August 22, 2028
• Study Completion (Estimated): August 28, 2028

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obstructive hypertrophic cardiomyopathy (oHCM)
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Cardiomyopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Cardiomyopathy, Hypertrophic; MYK-461
• Other Study ID Numbers: CV027-1210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes