Mavacamten treatment for obstructive hypertrophic cardiomyopathy in Japan
Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan
This project will try mavacamten in patients in Japan with obstructive hypertrophic cardiomyopathy to see if it works well and is safe during routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT07383025 on ClinicalTrials.gov |
What this trial studies
This is a post-marketing, observational surveillance program enrolling patients in Japan who start mavacamten for the approved indication. Data on real-world effectiveness and safety will be collected from participating medical institutions during the enrollment and follow-up periods. Patients receiving mavacamten for off-label indications will be excluded. The program is sponsored by Bristol-Myers Squibb with data coordination through CMIC Co., Ltd in Tokyo.
Who should consider this trial
Good fit: Patients in Japan with obstructive hypertrophic cardiomyopathy who initiate mavacamten for an approved indication at participating medical institutions during the enrollment period.
Not a fit: Patients receiving mavacamten for off-label indications, those with non-obstructive HCM, or patients not starting mavacamten will not be included and therefore will not directly benefit from this surveillance data.
Why it matters
Potential benefit: If successful, this could provide practical information on how well mavacamten works and how safe it is for Japanese patients with obstructive HCM in routine clinical practice.
How similar studies have performed: Randomized trials such as EXPLORER-HCM and VALOR-HCM demonstrated clinical benefit of mavacamten for obstructive HCM, and this program seeks to confirm effectiveness and safety in real-world Japanese practice.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tokyo
- CMIC Co., Ltd — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.