RecruitingNot Applicable

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

Japan200 participantsStarted 2025-05-21

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Up to 52 weeks

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

Timeframe: Up to 52 weeks

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

Timeframe: Up to 52 weeks

Trial details

NCT IDNCT07383025

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-11-30

Contact for this trial

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286 Clinical.Trials@bms.com

View on ClinicalTrials.gov More Obstructive Hypertrophic Cardiomyopathy (oHCM) trials