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Sponsor has designed another study to replace the current study
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The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | placebo in addition to standard therapy |
|
| rhNRG-1 | Experimental | rhNRG-1 in addition to standard therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhNRG-1 | Drug | 10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| sudden death | 1 year | |
| death caused by cardiovascular events | 1 year | |
| rehospitalization |
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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 | 10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks |
|
| 1 year |
| hospitalization caused by worsening heart failure | 1 year |
| cardiac function | 1 year |
| NYHA functional classification | 1 year |
| 6 minute walking distance | 1 year |
| quality of life | 1 year |
| Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Xuanwu hospital of Capital Medical University | 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 |
| Peking University First Hospital | Beijing | Beijing Municipality | China |
| The Xinqiao Hospital of Third Military Medical University | Chongqing | Chongqing Municipality | China |
| Fujian Provincial Hospital | Fuzhou | Fujian | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| The First Affiliated Hospital, Sun Yet-Sen University | Guangzhou | Guangdong | China |
| Haikou Municipal Peoples Hospital | Haikou | Hainan | China |
| Bethune Peace Hospital | 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 hospital affiliated to Zhengzhou University | Zhengzhou | Henan | China |
| Tongji Hospital Affiliated to Huazhong University of Science and Technology | Wuhan | Hubei | China |
| People's Hospital of Hunan Province | Changsha | Hunan | China |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | China |
| The Second Hospital affiliated to Suzhou University | Suzhou | Jiangsu | China |
| The Affiliated Hospital of Xuzhou Medical School | Xuzhou | Jiangsu | China |
| North Jiangsu People's Hospital | Yangzhou | Jiangsu | China |
| The Affiliate Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| The Second Hospital affiliated to 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 |
| The First Hospital of China Medical College | Shengyang | 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 |
| The Second Hospital of Shandong University | Jinan | Shandong | China |
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
| Renji Hospital, Medical School of Shanghai Jiaotong University | Shanghai | Shanghai Municipality | China |
| Ruijin Hospital, Medical School of Shanghai Jiaotong University | Shanghai | Shanghai Municipality | China |
| The first people's hospitial of Shanghai | Shanghai | Shanghai Municipality | China |
| The Sixth People's Hospital, Shanghai Jiaotong University | Shanghai | Shanghai Municipality | China |
| The Second Hospital of Shanxi Medical College | Taiyuan | Shanxi | China |
| The second hospital of Xi'an jiaotong university | Xi’an | Shanxi | China |
| Huaxi Hospital of Sichuan University | Chengdu | Sichuan | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | China |
| Kunming General Hospital of Chengdu Military Region | Kunming | Yunnan | China |
| The Second Hospital of Kunming Medical College | Kunming | Yunnan | China |
| Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| The First Hospital affiliated to School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| C565323 | Fibromatosis, Gingival, 2 |
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