Obstructive Hypertrophic Cardiomyopathy (oHCM)
Conditions
Keywords
Obstructive hypertrophic cardiomyopathy (oHCM)
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
Interventions
According to the product label
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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 |
Countries
Japan
Contacts
Bristol-Myers Squibb