Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the real-world outcomes of individuals diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) treated with mavacamten at the Hospital of The University of Pennsylvania in the US
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants prescribed mavacamten treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant New York Heart Association (NYHA) functional class | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks | |
| Participant echocardiogram measurements: Left ventricular outflow tract (LVOT) gradient results at rest, Valsalva and post-exercise (if available) | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks | |
| Participant echocardiogram measurements: Left ventricular ejection fraction (LVEF) percentage | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks | |
| Participant echocardiogram measurements: Maximum left ventricular wall thickness | Baseline, and at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 108 weeks | |
| Participant age | Baseline | |
| Participant gender | Baseline | |
| Participant race | Baseline | |
| Participant ethnicity | Baseline | |
| Participant insurance coverage | Baseline | |
| Participant Body Mass Index | Baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will comprise of adult individuals diagnosed with Obstructive Hypertrophic cardiomyopathy (oHCM) that have been prescribed mavacamten at The Hospital of the University of Pennsylvania between April 1, 2022 and January 17, 2025
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
Not provided
Not provided
| ID | Term |
|---|---|
| C000605992 | MYK-461 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participant blood pressure | Baseline |
| Participant heart rate | Baseline |
| Participant genotype | Baseline |
| Participant family history | Baseline |
| Participant New York Functional Class classification | Baseline |
| Participant echocardiogram measurements | Baseline |
| Participant comorbidities | Baseline |
| Participant hypertrophic cardiomyopathy (HCM) treatment history | Baseline |
| Mavacamten index dose prescribed | Baseline |
| Participant obstructive hypertrophic cardiomyopathy (oHCM) symptoms (syncope, shortness of breath, fatigue, exercise intolerance, palpitations) | Baseline |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |