Mavacamten Post-marketing Surveillance in Patients With O... | NCT07383025

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

NCT07383025

Sponsor

Bristol-Myers Squibb

Status

Recruiting

Last Update Posted

Feb 3, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Obstructive Hypertrophic Cardiomyopathy (oHCM)

Interventions

Mavacamten

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2025Actual

Primary Completion Date

Nov 30, 2029Estimated

Completion Date

Nov 30, 2029Estimated

First Submitted Date

Jan 26, 2026

First Submission Date that Met QC Criteria

Jan 26, 2026

First Posted Date

Feb 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Feb 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1		Participants with obstructive hypertrophic cardiomyopathy receiving mavacamten treatment	Drug: Mavacamten

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mavacamten	Drug	According to the product label	Cohort 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Bristol Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMIC Co., Ltd	Recruiting	Tokyo			Japan

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
FDA Safety Alerts and Recalls	View source

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001020	Aortic Stenosis, Subvalvular