A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive H… (NCT07361289) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
China500 participantsStarted 2026-01-15
Plain-language summary
The purpose of this study is to assess the effectiveness of mavacamten treatment in Chinese adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in real-world clinical practice
Who can participate
Age range
18 Years
Sex
ALL
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:
* Participants aged ≥ 18 years (participants enrolled retrospectively: at the time of initial mavacamten prescription), irrespective of gender.
* Participants who have initiated mavacamten (for whom enrolled retrospectively) or are scheduled to initiate mavacamten (for whom enrolled prospectively) based on clinical therapeutic needs.
* Diagnosed with obstructive hypertrophic cardiomyopathy (HCM) consistent with current American College of Cardiology Foundation/American Heart Association, European Society of Cardiology, and Chinese guidelines for diagnosis and treatment of patients with hypertrophic cardiomyopathy, i.e., satisfy criteria below:
* Has a documented diagnosis of HCM prior to enrollment, and
* Peak left ventricular outflow tract (LVOT) gradient ≥ 30 mmHg at rest or with provocation in the most recent medical record within 3 months prior to enrollment as assessed by echocardiography.
* Has documented left ventricular ejection fraction (LVEF) ≥ 55%, as measured by resting transthoracic echocardiography (TTE) in the most recent medical record within 3 months prior to enrollment.
* New York Heart Association (NYHA) class II or III symptoms in the most recent medical record within 3 months prior to enrollment.
* For participants enrolled retrospectively, essential baseline information\* and critical data\*\* must be traceable and available. At least one key follow-up time points\*\*\* is required for inclusion.
Note:
\* Essential baseline in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a real-world effectiveness study rather than a controlled clinical trial, can you explain what that means for me — will I be receiving mavacamten as part of my standard care and just being observed, or is there something additional required of me?
2The study is measuring changes in my LVOT gradient during the Valsalva maneuver and at rest — can you help me understand what my current LVOT gradient readings are and whether they suggest I might be a good fit to discuss this study with my care team?
3Mavacamten is already approved and being used in practice, but this study is collecting real-world data in Chinese patients specifically — does that mean there may be gaps in safety or dosing information for patients like me that this study is trying to fill?
4Before considering this study, should we talk about whether my current symptoms are well-controlled enough with existing medications or other treatments, or whether joining this study would be the right next step?
5What would the monitoring schedule look like if I were to participate — for example, how often would I need to come in for echocardiograms or LVOT gradient measurements, and is that realistic given my daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Valsalva left ventricular outflow tract (LVOT) gradient
Timeframe: Week 48, Week 96
2
Change from baseline in resting valsalva left ventricular outflow tract (LVOT) gradient
Timeframe: Week 48, Week 96
Trial details
NCT IDNCT07361289
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2028-08-22
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com