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The same protocol has been launched in United States.
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Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| rhNRG-1 | Experimental | recombinant human neuregulin-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhNRG-1 | Drug | Subcutaneous Administration:0.6ug/kg/day for 10days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac function measured by MRI | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac function | 6-minute walk test, cardiac function classification(NYHA),life quality score. | baseline, 30 days, 90day and180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao | Cardiovascular Institute and Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital of Capital University of Medical Sciences | Beijing | China | ||||
| Beijing Chaoyang Hospital, Capital Medical University |
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| rhNRG-1 |
| Drug |
Subcutaneous Administration 1.2ug/kg/day for 10 days |
|
| rhNRG-1 | Drug | Vein infusion:0.6ug/kg/day for 10 days |
|
| placebo | Drug | Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days |
|
| Beijing |
| China |
| Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | China |
| General Hospital of People's Liberation Army | Beijing | China |