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

June 17, 2026 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Withdrawn
        • Local Institution - 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in Valsalva left ventricular outflow tract (LVOT) gradient
Time Frame: Week 48, Week 96
Week 48, Week 96
Change from baseline in resting valsalva left ventricular outflow tract (LVOT) gradient
Time Frame: Week 48, Week 96
Week 48, Week 96

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in New York Heart Association (NYHA) class
Time Frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96
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
Time Frame: Week 12, Week 36, Week 48, Week 72, and Week 96
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)
Time Frame: Week 12, Week 36, Week 48, Week 72, and Week 96
Week 12, Week 36, Week 48, Week 72, and Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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