Hypertrophic CardiomyopathySOAR-HCMNCT07361289
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
An observational study of Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 15 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Mavacamten
- How many people
- 500 participants
- Where
- 15 sitesChina
- Study dates
- 15 Jan 2026to 28 Aug 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy that have received mavacamten treatment in China
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
15 sites in 1 country
China15 sites, 14 recruiting
- Not yet recruiting
Local Institution - 0008
Beijing, Beijing Municipality, 100029
Site 0008
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Zhuang Tian, Site 0001
- Recruiting
Peking University First Affiliated Hospital
Beijing, Beijing Municipality, 100034
Ma Wei, Site 0002, 86-13681050902
- Recruiting
The Second Hospital of Jilin University
Changchun, Jilin, 130041
Bin Liu, Site 0004, +86043188796598
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Yucheng Chen, Site 0012, +86 18980602149
- Not yet recruiting
Local Institution - 0005
Dalian, Liaoning, 116011
Site 0005
- Not yet recruiting
Local Institution - 0009
Guangzhou, Guangdong, 510080
Site 0009
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Xiaojie Xie, Site 0006
- Not yet recruiting
Local Institution - 0003
Harbin, Heilongjiang, 150086
Site 0003
- Recruiting
The Second Afilliated Hospital of Hebei Medical University
Jiazhuang, Hebei, 050000
Xinshun Gu, Site 0014, +86 13930139688
- Not yet recruiting
Local Institution - 0010
Jinan, 250012
Site 0010
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, 200032
Shuning Zhang, Site 0011, +86 15921766132
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Yan Chen, Site 0015, +86 18015571559
- Withdrawn
Local Institution - 0013
Xi'an, Shan3xi, 710061
- Not yet recruiting
Local Institution - 0007
Zhengzhou, Henan, 450052
Site 0007
About this study
Official title: 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
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Mavacamten
- Keywords
- Obstructive hypertrophic cardiomyopathy (oHCM)
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) receiving mavacamten Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Valsalva left ventricular outflow tract (LVOT) gradient
Measured: Week 48, Week 96
Change from baseline in resting valsalva left ventricular outflow tract (LVOT) gradient
Measured: Week 48, Week 96
Secondary outcomes (3)
Change from baseline in New York Heart Association (NYHA) class
Measured: 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
Measured: 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)
Measured: Week 12, Week 36, Week 48, Week 72, and Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Jan 2026
- Primary completion22 Aug 2028 (estimated)
- Study completion28 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361289
- Sponsor's protocol ID
- CV027-1210
- Acronym
- SOAR-HCM
- Status last verified
- Jun 2026
- First submitted
- 14 Jan 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No