The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
365
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
Time frame: 0, 7 days
Decrease rate in NT-proBNP compared to pre-treatment.
Time frame: 0, 7 days.
Decrease value in NT-proBNP compared to pre-treatment.
Time frame: 0, 7 days.
Likert rating scale of Dyspnoea.
Time frame: 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.
Time frame: 0, 7 days.
Heart function grade of NYHA.
Time frame: 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.
Time frame: 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.
Time frame: Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.
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An Hui Provincial Hospital
Hefei, Anhui, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Fourth People's Hospital of Shenzhen(Futian Hospital)
Shenzhen, Guangdong, China
Daqing peoples hospital
Daqing, Heilongjiang, China
Nanshi Hospital of Nanyang
Nanyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
...and 15 more locations