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The study is being conducted to evaluate the efficacy, and safety of HRS-1893 for obstructive hypertrophic cardiomyopathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1893 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1893 | Drug | HRS-1893 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The subjects' left ventricular outflow tract pressure gradient (Valsalva LVOT-G) was assessed for changes from the baseline after performing the Valsalva maneuver | After 12 weeks of HRS-1893 treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak oxygen uptake (pVO2) and carbon dioxide ventilation equivalent (VE/VCO2) | Baseline to Week 12 | |
| Change in LVEF | Baseline to Week 12 | |
| Change in LVOT-VTI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences (CAMS) | Beijing | Beijing Municipality | 100032 | China |
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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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| Baseline to Week 12 |
| Change in LV-FS | Baseline to Week 12 |
| Change in LV-GLS | Baseline to Week 12 |
| Change in Rest LVOT-G | Baseline to Week 12 |
| Change in Valsalva LVOT-G | Baseline to Week 12 |
| Change in cardiac troponin | Baseline to Week 12 |
| Change in NT-proBNP | Baseline to Week 12 |
| Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS) | Baseline to Week 12 |
| Proportion of participants with ≥ 1 class improvement in NYHA Functional Class | Baseline to Week 12 |
| Incidence and severity of any adverse events (AESI, SAE, TRAE, TEAE) | Through study completion, an average of 68 weeks |
| plasma concentration of HRS-1893 | Through study completion, an average of 68 weeks |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |