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The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with mavacamten | Patients with symptomatic obstructive hypertrophic cardiomyopathy (NYHA functional class II-III) who receive mavacamten as part of routine clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | As detailed in the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation |
| Up to 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation | Up to 1.5 years | |
| Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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The observational study will include adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who are enrolled in the Bristol Myers Squibb (BMS)-sponsored CAMZYOS Patient Support Program and who have initiated mavacamten as part of routine clinical care in Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Centre (LHSC) | London | Ontario | N6A 5A5 | Canada |
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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 |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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| Up to 1.5 years |
| Age | Baseline |
| Sex at birth | Baseline |
| Ethnicity | Baseline |
| Employment status | Baseline |
| Body mass index (BMI) | Baseline |
| Obstructive hypertrophic cardiomyopathy (oHCM) disease duration | Baseline |
| Proportion of patients in each New York Heart Association (NYHA) functional class II and III | Baseline |
| Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient | Baseline |
| Left ventricular ejection fraction by 2D echocardiogram (LVEFb) | Baseline |
| Mavacamten dose regimen | Up to 1.5 years |
| Proportion of patients who discontinued mavacamten | Up to 1.5 years |
| Duration of treatment prior to mavacamten discontinuation | Up to 1.5 years |
| Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation | Up to 1.5 years |
| Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation | Up to 1.5 years |
| Reason for discontinuing mavacamten treatment | Up to 1.5 years |
| Functional assessment schedule |
| Up to 1.5 years |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |