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

NCT07846059 | Not Yet Recruiting FDA Drug

• 1 other identifier: CV027-1262
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

Symptomatic obstructive hypertrophic cardiomyopathy (oHCM); Mavacamten; Hypertrophic cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• 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 (15)

• 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

Study Arms (5)

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

Mavacamten DRUG

As per product label

Category A1. Sustained Monotherapy; Category A2. Treatment Intensification; Category B1. Stable Combination Therapy at Initiation; Category B2. Treatment Simplification; Category C. Complex/Unclassifiable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, China

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)