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Sponsor has designed another study with different endpoint to replace the current study
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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 serum NT-proBNP, as well as safety in patients with chronic heart failure.
N-terminal proNBP (NT-proBNP) has been proved to be an independent prognostic factor for the long-term prognosis of chronic heart failure patients.RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it. It has been found that rhNRG-1 effectively decreased the serum level of NT-proBNP,and is tolerated in the effective dosages groups.The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively decrease the serum level of NT-proBNP 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 |
|
| Plaebo | 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 |
|---|---|---|
| NT-proBNP | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP | 90 days | |
| Six Minutes Walk Distance | 30 days and 90 days | |
| NYHA classification |
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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 |
|---|---|---|---|---|---|---|
| Cardiovascular Institute and Fuwai Hospital | Beijing | Beijing Municipality | China | |||
| Bethune Peace Hospital |
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| Placebo |
| Drug |
day1~day10:0.6ug/kg/day,10hours per day for vein infusion |
|
| 30 days and 90 days |
| Quality of Life | 30 days and 90 days |
| Shijiazhuang |
| Hebei |
| China |
| Teda International Cardiovascular Hospital | Tianjin | Hebei | China |
| Daqing Oilfield General Hospital | Daqing | Heilongjiang | China |
| The First Hospital of Harbin Medical University | Haerbin | Heilongjiang | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Sichuan Provincial People's Hospital | Chengdu | Jiangsu | China |
| The Second Hospital affiliated to Suzhou University | Suzhou | Jiangsu | China |
| North Jiangsu People's Hospital | Yangzhou | Jiangsu | China |
| The Affiliate Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| The Second Hospital of Jilin University | Changchun | Jilin | China |
| The First Hospital affiliated to Dalian Medical University | Dalian | Liaoning | China |
| The first affiliated hospital of Liaoning medical college | Jinzhou | Liaoning | China |
| Liaoning Provincial People's Hospital | Shenyang | Liaoning | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Shanghai First People's Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
| The Xinqiao Hospital of Third Military Medical University | Chongqing | Sichuan | China |
| Kunming General Hospital of Chengdu Military Region | Kunming | Yunnan | China |