A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Obstructive Hypertrophic Cardiomyopathy

Treatments: Drug: Mavacamten

Study type: Observational

Funder types: Industry

Identifiers

NCT06146660

CV027-1089

Details and patient eligibility

About

The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

Enrollment: 600 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants 19 years of age or older
• Participants who receive mavacamten according to the approved product label
• Participants who sign the informed consent form

Exclusion criteria

• Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
• Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety

Trial design

600 participants in 1 patient group

Participants receiving mavacamten for oHCM

Treatment:

Drug: Mavacamten