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

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)

Treatments: Drug: Mavacamten

Study type: Observational

Funder types: Industry

Identifiers

NCT07383025

CV027-1081

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Cohort 1

Description:

Participants with obstructive hypertrophic cardiomyopathy receiving mavacamten treatment

Treatment:

Drug: Mavacamten