Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy

NCT07846059 — Not yet recruiting, 800 participants, Bristol-Myers Squibb

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Real-world Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy

RegistryNCT07846059, acronym REMAP-HCM
StatusNot yet recruiting
Study typeObservational
Enrollment800 (Estimated)
SponsorBristol-Myers Squibb (Industry)
ConditionsObstructive Hypertrophic Cardiomyopathy (oHCM)
InterventionsMavacamten (Drug)
Datesstart 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
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Obstructive Hypertrophic Cardiomyopathy (oHCM) All trials of Mavacamten

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Category A1. Sustained MonotherapyDrug: MavacamtenParticipants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up.
Category A2. Treatment IntensificationDrug: MavacamtenParticipants 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 InitiationDrug: MavacamtenParticipants who initiate mavacamten with one or more background obstructive hypertrophic cardiomyopathy (oHCM) medications and remain on combination therapy throughout follow-up.
Category B2. Treatment SimplificationDrug: MavacamtenParticipants 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/UnclassifiableDrug: MavacamtenParticipants whose treatment records indicate multiple treatment changes that could not be classified into the predefined treatment strategy groups.
  • Mavacamten (Drug): As per product label

+Outcome measures

Primary outcomes

  • Number of participants in each study cohort [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 [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 [Baseline and at months 1, 2, 3, 6, 9, 12 and 15]

Secondary outcomes

  • Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class [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 [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 [Baseline and at months 1, 2, 3, 6, 9, 12 and 15]
  • Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography [Baseline and at months 1, 2, 3, 6, 9, 12 and 15]
  • Change from baseline in E/e' ratio assessed by transthoracic echocardiography [Baseline and months 1, 2, 3, 6, 9, 12 and 15]
  • Prescribed mavacamten dose (mg) [Day 1 and months 1, 2, 3, 6, 9, 12 and 15]
  • Prescribed mavacamten maintenance dose (mg) during follow-up [Up to 15 months]
  • Number of participants reaching mavacamten maintenance dose [Up to 15 months]
  • Number of participants whose prescribed mavacamten dose changed during the observation period [Day 1 and and up to 15 months]
  • Time (days) from Index Date to achieving mavacamten maintenance dose [Day 1 and up to 15 months]
  • Number of participants that discontinued mavacamten treatment [Up to 15 months]
  • Time (days) from Index Date to mavacamten discontinuation [Day 1 and up to 15 months]
  • Duration of mavacamten treatment during follow-up [Day 1 and up to 15 months]
  • Prior hypertrophic cardiomyopathy (oHCM) medication drug class [Baseline and up to 15 months]: Drug class of background oHCM medications, including beta-blockers and calcium channel blockers
  • Prior hypertrophic cardiomyopathy (oHCM) medication dose [Baseline and up to 15 months]: Dose of background oHCM medications, including beta-blockers and calcium channel blockers

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Fudan University Zhongshan HospitalShanghaiChina

+Investigators

  • Bristol-Myers Squibb, Study director, Bristol-Myers Squibb