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Not yet recruitingNCT07846059REMAP-HCMUpdated Sep 29, 2026

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

An observational study in Obstructive Hypertrophic Cardiomyopathy (oHCM), sponsored by Bristol-Myers Squibb. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

  • Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)
  • Mavacamten
  • Hypertrophic cardiomyopathy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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.

04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Category A1. Sustained Monotherapy

    Participants who initiate mavacamten as monotherapy and remained on monotherapy throughout follow-up.

    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.

    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.

    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.

    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.

    Drug: Mavacamten

Interventions

  • DrugMavacamten

    As per product label

05

What researchers measure

Primary outcomes

  1. Number of participants in each study cohort

    Time frame: Baseline and months 1, 2, 3, 6, 9, 12 and 15

  2. Absolute change (mmHg) from baseline in resting peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography

    Time frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15

  3. Absolute change (mmHg) from baseline in post-Valsalva peak left ventricular outflow tract (LVOT) gradient assessed by transthoracic echocardiography

    Time frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15

Secondary outcomes

  1. Number of participants with at least 1-class improvement from baseline in New York Heart Association (NYHA) functional class

    Time frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15

  2. New York Heart Association (NYHA) functional class classification as assessed by the treating physician

    Time frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15

  3. Change from baseline in left atrial dimension (LAD) or left atrial volume index (LAVI) assessed by transthoracic echocardiography

    Time frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15

  4. Change from baseline in interventricular septal thickness (IVST) assessed by transthoracic echocardiography

    Time frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15

  5. Change from baseline in E/e' ratio assessed by transthoracic echocardiography

    Time frame: Baseline and months 1, 2, 3, 6, 9, 12 and 15

  6. Prescribed mavacamten dose (mg)

    Time frame: Day 1 and months 1, 2, 3, 6, 9, 12 and 15

  7. Prescribed mavacamten maintenance dose (mg) during follow-up

    Time frame: Up to 15 months

  8. Number of participants reaching mavacamten maintenance dose

    Time frame: Up to 15 months

  9. Number of participants whose prescribed mavacamten dose changed during the observation period

    Time frame: Day 1 and and up to 15 months

  10. Time (days) from Index Date to achieving mavacamten maintenance dose

    Time frame: Day 1 and up to 15 months

  11. Number of participants that discontinued mavacamten treatment

    Time frame: Up to 15 months

  12. Time (days) from Index Date to mavacamten discontinuation

    Time frame: Day 1 and up to 15 months

  13. Duration of mavacamten treatment during follow-up

    Time frame: Day 1 and up to 15 months

  14. Prior hypertrophic cardiomyopathy (oHCM) medication drug class

    Drug class of background oHCM medications, including beta-blockers and calcium channel blockers

    Time frame: Baseline and up to 15 months

  15. Prior hypertrophic cardiomyopathy (oHCM) medication dose

    Dose of background oHCM medications, including beta-blockers and calcium channel blockers

    Time frame: Baseline and up to 15 months

06

Study locations

1 site
  • Fudan University Zhongshan Hospital
    Shanghai, China
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07846059
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Sep 29, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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