Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy
| Registry | NCT07846059, acronym REMAP-HCM |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 800 (Estimated) |
| Sponsor | Bristol-Myers Squibb (Industry) |
| Conditions | Obstructive Hypertrophic Cardiomyopathy (oHCM) |
| Interventions | Mavacamten (Drug) |
| Dates | start 2026-09-30 (estimated), primary completion 2027-03-31 (estimated), completion 2027-04-30 (estimated), first posted 2026-09-29, last updated 2026-09-29 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Obstructive Hypertrophic Cardiomyopathy (oHCM) All trials of Mavacamten
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Category A1. Sustained Monotherapy | Drug: Mavacamten | Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up. | |
| Category A2. Treatment Intensification | Drug: Mavacamten | Participants who initiate mavacamten monotherapy and subsequently added one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications during follow-up. | |
| Category B1. Stable Combination Therapy at Initiation | Drug: Mavacamten | Participants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and remain on combination therapy throughout follow-up. | |
| Category B2. Treatment Simplification | Drug: Mavacamten | 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. | |
| Category C. Complex/Unclassifiable | Drug: Mavacamten | Participants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: Participants must meet all of the following criteria to be included: 1. 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. 2. 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. 3. Age: Be ≥ 18 years of age at the Index Date. 4. 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. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: (1) 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Fudan University Zhongshan Hospital | Shanghai | China |