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| ID | Type | Description | Link |
|---|---|---|---|
| 007119 | Other Identifier | UMKC |
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| Name | Class |
|---|---|
| Saint Lukes Hospital Mid America Heart Institute | UNKNOWN |
| Cytokinetics | INDUSTRY |
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This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMI | Experimental | Switching from mavacamten on day 1 to aficamten starting at week 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aficamten | Drug | Patients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | To describe the safety of this proposed protocol. These include:
| Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment | Up to 16 weeks | |
| Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg | Up to 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Masri | Contact | 503-494-7551 | masria@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Hospital - Mid America Heart Institute | Not yet recruiting | Kansas City | Missouri | 64111 | United States |
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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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This is a single group study where patients will transition from mavacamten to aficamten following a standardized protocol
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| Proportional change from baseline in NT-proBNP and high-sensitivity troponin I | Up to 16 weeks |
| Proportional improvement in NYHA functional classification by 1 functional class | Up to 16 weeks |
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |