Evaluation of Mavacamten-Based Practice in Chinese Adults With Obstructive Hypertrophic Cardiomyopathy (REMAP-HCM)

September 23, 2026 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • China
      • Shanghai, China
        • Fudan University Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: RETROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Category A1. Sustained Monotherapy

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

As per product label
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

As per product label
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

As per product label
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

As per product label
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

As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants in each study cohort
Time Frame: Baseline and months 1, 2, 3, 6, 9, 12 and 15
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
Time Frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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
Time Frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Baseline and at months 1, 2, 3, 6, 9, 12 and 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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
Time Frame: Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
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
Baseline and at months 1, 2, 3, 6, 9, 12 and 15
Change from baseline in E/e' ratio assessed by transthoracic echocardiography
Time Frame: Baseline and months 1, 2, 3, 6, 9, 12 and 15
Baseline and months 1, 2, 3, 6, 9, 12 and 15
Prescribed mavacamten dose (mg)
Time Frame: Day 1 and months 1, 2, 3, 6, 9, 12 and 15
Day 1 and months 1, 2, 3, 6, 9, 12 and 15
Prescribed mavacamten maintenance dose (mg) during follow-up
Time Frame: Up to 15 months
Up to 15 months
Number of participants reaching mavacamten maintenance dose
Time Frame: Up to 15 months
Up to 15 months
Number of participants whose prescribed mavacamten dose changed during the observation period
Time Frame: Day 1 and and up to 15 months
Day 1 and and up to 15 months
Time (days) from Index Date to achieving mavacamten maintenance dose
Time Frame: Day 1 and up to 15 months
Day 1 and up to 15 months
Number of participants that discontinued mavacamten treatment
Time Frame: Up to 15 months
Up to 15 months
Time (days) from Index Date to mavacamten discontinuation
Time Frame: Day 1 and up to 15 months
Day 1 and up to 15 months
Duration of mavacamten treatment during follow-up
Time Frame: Day 1 and up to 15 months
Day 1 and up to 15 months
Prior hypertrophic cardiomyopathy (oHCM) medication drug class
Time Frame: Baseline and up to 15 months

Drug class of background oHCM medications, including beta-blockers and calcium channel blockers
Baseline and up to 15 months
Prior hypertrophic cardiomyopathy (oHCM) medication dose
Time Frame: Baseline and up to 15 months

Dose of background oHCM medications, including beta-blockers and calcium channel blockers
Baseline and up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

September 23, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 29, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-1262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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