Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (NCT07529938) | Clinical Trial Compass
CompletedNot Applicable
Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy
China222 participantsStarted 2024-01-01
Plain-language summary
This retrospective cohort study aims to evaluate the clinical efficacy and safety of mavacamten in adult patients with obstructive hypertrophic cardiomyopathy (oHCM). A total of 222 patients were included and categorized based on treatments received in routine clinical practice into a mavacamten group and a standard therapy group.
The primary outcome is the change in resting left ventricular outflow tract (LVOT) gradient at Week 30. Secondary outcomes include changes in Valsalva LVOT gradient, New York Heart Association (NYHA) functional class, cardiac biomarkers, and echocardiographic parameters. Safety outcomes include adverse events and left ventricular systolic dysfunction.
This study provides real-world evidence on the effectiveness and safety of mavacamten in Chinese patients with oHCM.
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:
* Age ≥18 years
* Diagnosis of hypertrophic cardiomyopathy
* NYHA functional class II-III
* First-time treatment with mavacamten
Exclusion Criteria:
* Known hypersensitivity to mavacamten or its components
* Left ventricular ejection fraction (LVEF) \<55%
* Septal reduction therapy within 6 months prior to enrollment
* Presence of other conditions requiring long-term anticoagulation
* Pregnancy or breastfeeding
* Any condition deemed unsuitable by the investigator
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 in Resting Left Ventricular Outflow Tract (LVOT) Peak Gradient at Week 30
Timeframe: Baseline to Week 30
Trial details
NCT IDNCT07529938
SponsorChinese Academy of Medical Sciences, Fuwai Hospital