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This study aims to evaluate the safety and tolerability of HRS-1893 in subjects with heart failure with preserved ejection fraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1893 Tablet Group | Experimental |
| |
| HRS-1893 Tablet Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1893 Tablet | Drug | HRS-1893 tablet. |
| |
| HRS-1893 Tablet Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs). | In heart failure patients with preserved ejection fraction after treatment with HRS-1893. | Week 24. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in N-terminal pro B-type natriuretic peptide (NT-proBNP). | In heart failure patients with preserved ejection fraction after treatment with HRS-1893. | Week 12 and Week 24. |
| Change from baseline in Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhong Lv | Contact | +86-0518-82342973 | jianhong.lv.jl9@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Drug |
HRS-1893 tablet placebo. |
|
In heart failure patients with preserved ejection fraction after treatment with HRS-1893. |
| Week 12 and Week 24. |
| Proportion of heart failure patients with preserved ejection fraction with an improvement of ≥1 NYHA functional class from baseline. | In heart failure patients with preserved ejection fraction after treatment with HRS-1893. | Week 12 and Week 24. |
| Change from baseline in total distance walked during the six-minute walk test (6MWT). | In heart failure patients with preserved ejection fraction after treatment with HRS-1893. | Week 12 and Week 24. |
| Change from baseline in resting left ventricular ejection fraction (LVEF). | In heart failure patients with preserved ejection fraction after treatment with HRS-1893. | Week 12 and Week 24. |
| Plasma concentration of HRS-1893. | In heart failure patients with preserved ejection fraction after treatment with HRS-1893. | Up to about 29 weeks. |