Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

NCT07383025 | Recruiting FDA Drug

• 1 other identifier: CV027-1081
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords

Obstructive hypertrophic cardiomyopathy (oHCM)

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (AEs) and/or serious AEs (SAEs)

  Up to 52 weeks

• Actions taken after adverse events (AEs) and/or serious AEs (SAEs)

  Up to 52 weeks

• Outcome of adverse events (AEs) and/or serious AEs (SAEs)

  Up to 52 weeks

Study Arms (1)

Cohort 1

Participants with obstructive hypertrophic cardiomyopathy receiving mavacamten treatment

Drug: Mavacamten

Interventions

Mavacamten DRUG

According to the product label

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) who initiate mavacamten treatment at medical institutions in Japan

You may qualify if:

• All obstructive hypertrophic cardiomyopathy (oHCM) patients who initiate treatment with Mavacamten of the approved indications at medical institutions in Japan during enrollment period will be enrolled in this regulatory post-marketing surveillance (PMS) study

You may not qualify if:

• Participants receiving Mavacamten for an off-label indication will be excluded from this PMS study

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

CMIC Co., Ltd

Tokyo, Japan

RECRUITING

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 Study Connect Contact Center www.BMSStudyConnect.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: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: May 21, 2025
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)