Mavacamten outcomes and real-world patient and physician experiences for obstructive HCM in the US
Mavacamten Real-World OutcomeS and the Associated PAtient and Physician ExpeRienCe With Hypertrophic CardioMyopathy in the United States (US) Community
See how mavacamten works and what patients and doctors experience for adults with obstructive hypertrophic cardiomyopathy treated in US community practice.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 362 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Bollington, Macclesfield) |
| Trial ID | NCT07557498 on ClinicalTrials.gov |
What this trial studies
This observational project collects real-world clinical data and experience from adults with obstructive hypertrophic cardiomyopathy who were prescribed mavacamten in US community-based settings. Phase I uses a retrospective chart review of patients prescribed mavacamten between April 28, 2022 and December 31, 2024 who were not enrolled in interventional cardiac myosin inhibitor trials. Phase II invites eligible Phase I patients to complete an online survey if they can read English and have access to a computer or smartphone. Data sources include medical records and patient/physician questionnaires to characterize treatment patterns, clinical outcomes, and experiences with mavacamten.
Who should consider this trial
Good fit: Adults (aged 18+) with confirmed obstructive HCM who were prescribed mavacamten at a participating site between April 28, 2022 and December 31, 2024, are not enrolled in interventional cardiac myosin inhibitor trials, and (for Phase II) can read English and use a computer or smartphone.
Not a fit: People who were never prescribed mavacamten, are under 18, are currently enrolled in an interventional cardiac myosin inhibitor trial, or (for survey participation) cannot read English or access a smartphone/computer are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, the findings could help clinicians and patients understand real-world benefits, risks, and usage patterns of mavacamten to inform treatment decisions.
How similar studies have performed: Randomized trials such as EXPLORER-HCM and VALOR-HCM have shown mavacamten improves symptoms and outflow gradients, while real-world observational data remain limited but are emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Phase I: retrospective chart review For inclusion in the study, participants must meet ALL of the following criteria: * Are an adult aged 18 or over at baseline * Have a confirmed diagnosis of obstructive hypertrophic cardiomyopathy (HCM) * Have been prescribed mavacamten for obstructive HCM at one of the study sites between 28th April 2022 and 31st December 2024 * Have not ever been enrolled in any interventional clinical trial involving any cardiac myosin inhibitor (enrollment in observational studies is permitted) * Are not enrolled in any interventional clinical trial at study baseline Phase II: patient survey • Participants must meet all inclusion criteria of Phase I: retrospective chart review and be able to read and understand English and have access to computer or smartphone to complete the survey Exclusion Criteria: • None with the proviso that all inclusion criteria are met.
Where this trial is running
Bollington, Macclesfield
- Adelphi Real World — Bollington, Macclesfield, United Kingdom (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.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.