Mavacamten treatment for obstructive hypertrophic cardiomyopathy in Japan
Official title: Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy (oHCM) in Japan
Run by Bristol-Myers Squibb · NCT07383025 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Status | Recruiting |
| Started | May 21, 2025 |
| Main results expected | November 30, 2029 |
| Study ends | November 30, 2029 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT07383025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Patients in Japan with obstructive hypertrophic cardiomyopathy who initiate mavacamten for an approved indication at participating medical institutions during the enrollment period.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
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Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US
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This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.
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This study is testing if the medication mavacamten can improve blood flow in the hearts of people with obstructive hypertrophic cardiomyopathy after a year of treatment.
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Registry to assess patient characteristics and outcomes in obstructive hypertrophic cardiomyopathy
This study is trying to learn more about how people with obstructive hypertrophic cardiomyopathy are treated and what their experiences are, especially for those using the medication mavacamten.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.