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 range18 Years
SexALL
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Inclusion Criteria:
* Participants aged ≥ 18 years (participants enrolled retrospectively: at the time of initial mavacamten prescription), irrespective of gender.
* 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 unexplained left ventricular (LV) hypertrophy with non-dilated ventricular chambers in the absence of other cardiac (e.g., hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy) in the most recent medical record within 3 months 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.
* Participants who have initiated mavacamten (for whom enrolled retrospectively) or are scheduled to initiate mavacamte…
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