A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
NCT ID: NCT02135835
Last Updated: 2018-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
365 participants
INTERVENTIONAL
2014-09-03
2017-03-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Shenfu Zhusheye
80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.
Shenfu Zhusheye
5% glucose injection
5% glucose injection
150 ml 5% glucose injection, ivdrip, once a day for 7 days.
5% glucose injection
Interventions
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Shenfu Zhusheye
5% glucose injection
Eligibility Criteria
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Inclusion Criteria
* LVEF≤40%.
* NT-pro-BNP ≥1400 pg/mL or BNP ≥ 350pg/mL.
* Ages 18-80, male or female.
* All participants signed the informed consent.
Exclusion Criteria
* SBP ≥ 150mmHg.
* Participants with severe chronic asthmatic bronchitis or acute episode of lung diseases.
* Participants with acute coronary syndrome, cardiogenic shock, aortic dissection, pulmonary embolism, severe ventricular arrhythmias, complete atrioventricular block without cardiac pacemaker, hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy and severe valvular disease without surgery.
* Participants with advanced cancer.
* Breastfeeding, pregnant and potentially fertile women participant.
* Participants with insanity.
* Known allergies with Shenfu Zhusheye or its ingredients in the past.
* Participants who have taken part in other clinical trials in last month.
* Participants who abuse alcohol or other drugs in last year.
* Participants who are not suitable for clinical trial under doctors' consideration.
18 Years
80 Years
ALL
No
Sponsors
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China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jiefu Yang
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital
Locations
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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
The First Hospital of Jilin University
Changchun, Jilin, China
The Fouth Affiliated Hospital of China Mdical University
Shenyang, Liaoning, China
The People's Hospital of Liao Ning Province
Shenyang, Liaoning, China
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Hospital (T.C.M.) Affiliated to Sichuan Medical
Luzhou, Sichuan, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
The First Affiliated Hospital of the Medical College,Shihezi University
Shihezi, XIjiangweiwuerzizhiqu, China
The First Affiliated Hospital of Xinjiang Medical
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiangweiwuerzizhiqu, China
Tongde hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Beijing Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Shang Hai Chest Hospital Shanghai JiaoTong University
Shanghai, , China
Countries
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Other Identifiers
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1312-Z-SHFU-ZS-RE
Identifier Type: -
Identifier Source: org_study_id
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