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Sponsor has designed another study with different endpoint to replace the current study
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This is a multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart failure.
RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling and is tolerated in patients with chronic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhNRG-1 | Active Comparator | Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure |
|
| Placebo | Placebo Comparator | Excipient placebo in addition to basic therapy of chronic heart failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhNRG-1 | Drug | day1~day10:0.6ug/kg/day,10hours per day for vein infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | 90 days | |
| N-terminal pro-BNP | 30 days and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Runlin Gao, MD, Ph.D | Cardiovascular Institute and Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences | Beijing | Beijing Municipality | China | |||
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| Placebo |
| Drug |
day1~day10:0.6ug/kg/day,10hours per day for vein infusion |
|
| Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences |
| Beijing |
| Beijing Municipality |
| China |
| Cardiovascular Institute and Fuwai Hospital | Beijing | Beijing Municipality | China |
| General Hospital of Chinese People's Liberation Army | Beijing | Beijing Municipality | China |