Obstructive Hypertrophic Cardiomyopathy (oHCM)REMAP-HCMNCT07846059
Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Bristol-Myers Squibb at 1 site in China.
Trial summary
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Mavacamten
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 30 Apr 2027
- 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 will include adults in China diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) who initiated mavacamten treatment between 24 October 2024 and 31 March 2026.
Who may be able to join
- Participants must meet all of the following criteria to be included:
- Diagnosis: Have a documented diagnosis of obstructive hypertrophic cardiomyopathy (oHCM), identified by the corresponding International Classification of Diseases (ICD)-10 codes in the medical record system.
- Medication Exposure: Have a first-ever recorded prescription for Mavacamten within the Patient Identification Period (24 October 2024 to 31 March 2026). This date is defined as the Index Date.
- Age: Be ≥ 18 years of age at the Index Date.
- Treatment Continuity: Have at least two valid clinical records of any type (e.g., outpatient visit, inpatient encounter, prescription refill, laboratory test, or echocardiogram) after the Index Date.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Prior Use of Study Drug: Have any documented history of Mavacamten use (based on medical history records, prescription records, or clinical notes) at any time prior to the Index Date.
Trial locations and contacts
1 site 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
About this study
Official title: Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
The study will describe how mavacamten is used in routine care for Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), including use as monotherapy or with other background/concomitant oHCM medications.
- Being tested
- Mavacamten
- Keywords
- Symptomatic obstructive hypertrophic cardiomyopathy (oHCM), Mavacamten, Hypertrophic cardiomyopathy
- 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
As per product label
| Study group | Role | What they receive |
|---|---|---|
| Category A1. Sustained Monotherapy | Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up. Receives: Drug: Mavacamten | |
| Category A2. Treatment Intensification | Participants who initiate mavacamten monotherapy and subsequently added one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications during follow-up. Receives: Drug: Mavacamten | |
| Category B1. Stable Combination Therapy at Initiation | Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and remain on combination therapy throughout follow-up. Receives: Drug: Mavacamten | |
| Category B2. Treatment Simplification | Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and subsequently discontinued all background oHCM medications, resulting in mavacamten monotherapy. Receives: Drug: Mavacamten | |
| Category C. Complex/Unclassifiable | Participants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups. Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each study cohort
Measured: Baseline and months 1, 2, 3, 6, 9, 12 and 15
Absolute change (mmHg) from baseline in resting peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Measured: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography
Measured: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Secondary outcomes (15)
Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class
Measured: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
New York Heart Association (NYHA) functional class classification as assessed by the treating physician
Measured: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography
Measured: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography
Measured: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Change from baseline in E/e' ratio assessed by transthoracic echocardiography
Measured: Baseline and months 1, 2, 3, 6, 9, 12 and 15
Prescribed mavacamten dose (mg)
Measured: Day 1 and months 1, 2, 3, 6, 9, 12 and 15
Prescribed mavacamten maintenance dose (mg) during follow-up
Measured: Up to 15 months
Number of participants reaching mavacamten maintenance dose
Measured: Up to 15 months
Number of participants whose prescribed mavacamten dose changed during the observation period
Measured: Day 1 and and up to 15 months
Time (days) from Index Date to achieving mavacamten maintenance dose
Measured: Day 1 and up to 15 months
Number of participants that discontinued mavacamten treatment
Measured: Up to 15 months
Time (days) from Index Date to mavacamten discontinuation
Measured: Day 1 and up to 15 months
Duration of mavacamten treatment during follow-up
Measured: Day 1 and up to 15 months
Prior hypertrophic cardiomyopathy (oHCM) medication drug class
Drug class of background oHCM medications, including beta-blockers and calcium channel blockers
Measured: Baseline and up to 15 months
Prior hypertrophic cardiomyopathy (oHCM) medication dose
Dose of background oHCM medications, including beta-blockers and calcium channel blockers
Measured: Baseline and up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)Studies 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
- Retrospective
- Enrolment
- 800 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
- NCT07846059
- Sponsor's protocol ID
- CV027-1262
- Acronym
- REMAP-HCM
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No