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The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) receiving cibenzoline in Japan
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch Group | Participants who discontinue cibenzoline before or at the initiation of mavacamten treatment |
| |
| Tapering/Add-on Group | Participants who continue cibenzoline at the initiation of mavacamten treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in either resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradient whichever used to judge the initiation of mavacamten treatment | Baseline and up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Outflow Tract (LVOT) peak gradient (resting and Valsalva maneuver) | Baseline and up to week 16 | |
| Proportion of patients achieving target Left Ventricular Outflow Tract (LVOT) peak gradients (<50 mmHg / <30 mmHg) (Valsalva maneuver or post-exercise) |
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Inclusion Criteria:
• Signed informed consent form (ICF): Participants, or their legally acceptable representative, must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved ICF in accordance with regulatory, local, and institutional guidelines. This must be obtained before the performance of any protocol-related procedures.
Diagnosed with obstructive hypertrophic cardiomyopathy (HOCM) consistent with Japanese Circulation Society guidelines (2025), i.e., satisfy all criteria below:
Has documented Left Ventricular Ejection Fraction (LVEF) ≥ 55% at baseline.
Participants who meet any of the following criteria:
Treated with a stable dose of cibenzoline for at least 3 months prior to initiating mavacamten treatment. Tapered cibenzoline within 3 months prior to initiating mavacamten treatment is allowed if stable dose of cibenzoline was used for at least 3 months prior to tapering.
At least 18 years of age at the time of signing the informed consent.
Exclusion Criteria:
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The study population will consist of adults diagnosed with symptomatic obstructive hypertrophic cardiomyopathy (HOCM) who have been prescribed mavacamten treatment by the treating physician as part of routine clinical care, in Japan
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristo Myers Squibb | Bristo Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mebix. Inc | Recruiting | Minato-ku | Tokyo | 1050001 | Japan |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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| Baseline and up to week 16 |
| Proportion of patients with any decrease in resting or Valsalva Left Ventricular Outflow Tract (LVOT) peak gradients | Baseline and up to week 16 |
| Proportion of patients with ≥1 New York Heart Association (NYHA) functional class improvement | Baseline and up to week 16 |
| Change in cardiac biomarkers from baseline | Biomarkers include brain natriuretic peptide (BNP) or N-terminal prohormone of BNP (NT-proBNP) | Baseline and up to week 16 |
| Change in systolic function parameters (left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Number of participants with Left Ventricular Ejection Fraction (LVEF) <50% as assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in left ventricular cardiac output (LVCO) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in early diastolic mitral annular velocity (e') measured at the lateral, septal, and averaged positions from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in E/e' ratio measured at the lateral, septal, and averaged positions and E/A ratio (ratio of early (E) to late (A) ventricular filling velocities) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in cardiac structural dimensions from baseline assessed by transthoracic echocardiography (TTE) | Structural dimensions include: septal thickness, posterior wall thickness, maximal left ventricular wall thickness, left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and left atrial dimension | Baseline and up to week 16 |
| Change in left ventricular outflow tract (LVOT) gradient measured at rest and during Valsalva maneuver from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in cardiac chamber volumes (left ventricular end-diastolic volume, left ventricular end-systolic volume, and left atrial volume) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in indexed cardiac chamber volumes (left ventricular end-diastolic volume index, left ventricular end-systolic volume index, and left atrial volume index) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in left ventricular diameters (left ventricular end-diastolic diameter and left ventricular end-systolic diameter) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in indexed left ventricular diameters (left ventricular end-diastolic diameter index and left ventricular end-systolic diameter index) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in left atrial dimension from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in left ventricular mass index (LVMI) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Number of participants with systolic anterior motion (SAM) of the mitral valve, and number of participants with mitral regurgitation (MR) assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Number of treatment emergent adverse events (TEAEs)/adverse drug reactions (ADRs) and serious TEAEs/ADRs | Up to week 16 |
| Proportion of participants continuing cibenzoline | Baseline and weeks 4, 8, 12, and 16 |
| Proportion of patients who decrease or increase dose and/or frequency of cibenzoline, beta blocker, or calcium channel blocker | Baseline and weeks 4, 8, 12, and 16 |
| Daily dose of cibenzoline, beta blocker, or calcium channel blocker | Baseline and weeks 4, 8, 12, and 16 |
| Change in Left Ventricular Ejection Fraction (LVEF) as assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| Change in left ventricular stroke volume (LVSV) from baseline assessed by transthoracic echocardiography (TTE) | Baseline and up to week 16 |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |