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The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shenfu Zhusheye | Experimental | 80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days. |
|
| 5% glucose injection | Placebo Comparator | 150 ml 5% glucose injection, ivdrip, once a day for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenfu Zhusheye | Drug |
| ||
| 5% glucose injection |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment. | 0, 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease rate in NT-proBNP compared to pre-treatment. | 0, 7 days. | |
| Decrease value in NT-proBNP compared to pre-treatment. | 0, 7 days. | |
| Likert rating scale of Dyspnoea. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiefu Yang | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| An Hui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| Fujian Provincial Hospital |
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|
| 0, 7 days. |
| The results of Transthoracic Doppler-echocardiography . | Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography. | 0, 7 days. |
| Heart function grade of NYHA. | 0, 7 days. |
| Composite endpoints. | Composite endpoints were defined as death, cardiac arrest with resuscitation, readmission for heart failure, worsening heart failure with an intravenous pharmacologic agent for more than 4 hours, stroke or cases where the patient ceased active treatments because of worsening heart failure. | Composite endpoints will be assessed during medication period and 28 days after medication. |
| Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, electrocardiogram. | Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days. |
| Fuzhou |
| Fujian |
| 350001 |
| China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| The Fourth People's Hospital of Shenzhen(Futian Hospital) | Shenzhen | Guangdong | 518033 | China |
| Daqing peoples hospital | Daqing | Heilongjiang | 163000 | China |
| Nanshi Hospital of Nanyang | Nanyang | Henan | 473000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The Fouth Affiliated Hospital of China Mdical University | Shenyang | Liaoning | 110032 | China |
| The People's Hospital of Liao Ning Province | Shenyang | Liaoning | 110032 | China |
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| The First Affiliated Hospital Of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Hospital (T.C.M.) Affiliated to Sichuan Medical | Luzhou | Sichuan | 646000 | China |
| The Second People's Hospital of Yibin | Yibin | Sichuan | 644000 | China |
| The First Affiliated Hospital of the Medical College,Shihezi University | Shihezi | XIjiangweiwuerzizhiqu | 832000 | China |
| The First Affiliated Hospital of Xinjiang Medical | Ürümqi | Xinjiang | 830054 | China |
| The Second Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiangweiwuerzizhiqu | 830000 | China |
| Tongde hospital of Zhejiang Province | Hangzhou | Zhejiang | 310012 | China |
| Beijing Hospital | Beijing | 100730 | China |
| Chinese PLA General Hospital | Beijing | 100853 | China |
| Shang Hai Chest Hospital Shanghai JiaoTong University | Shanghai | 200030 | China |
| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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