A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
- Conditions
- Acute Heart Failure
- Interventions
- Drug: Shenfu ZhusheyeDrug: 5% glucose injection
- Registration Number
- NCT02135835
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
- Clinical diagnosis of Acute Heart Failure according to Guidelines for the diagnosis and treatment of acute heart failure 2010 of Chinese Medical Association(Participants whose Heart function grade of NYHA is Ⅲ～Ⅳ).
- LVEF≤40%.
- NT-pro-BNP ≥1400 pg/mL or BNP ≥ 350pg/mL.
- Ages 18-80, male or female.
- All participants signed the informed consent.
- Participants with abnormal liver function (ALT, AST≥3 times of upper limit of normal) or abnormal kidney function( Cr≥1.5 times of upper limit of normal or Cr >3.0 mg/dl (> 265 µmol/L)).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Shenfu Zhusheye Shenfu Zhusheye 80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days. Shenfu Zhusheye 5% glucose injection 80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days. 5% glucose injection 5% glucose injection 150 ml 5% glucose injection, ivdrip, once a day for 7 days.
- Primary Outcome Measures
Name Time Method Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment. 0, 7 days
- Secondary Outcome Measures
Name Time Method Heart function grade of NYHA. 0, 7 days. 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. 0, 7 days. The results of Transthoracic Doppler-echocardiography . 0, 7 days. Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography.
Composite endpoints. Composite endpoints will be assessed during medication period and 28 days after medication. 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.
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.
Trial Locations
- Locations (25)
An Hui Provincial Hospital
🇨🇳Hefei, Anhui, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of the Medical College,Shihezi University
🇨🇳Shihezi, XIjiangweiwuerzizhiqu, China
Tongde hospital of Zhejiang Province
🇨🇳Hangzhou, Zhejiang, China
Daqing peoples hospital
🇨🇳Daqing, Heilongjiang, China
Hospital (T.C.M.) Affiliated to Sichuan Medical
🇨🇳Luzhou, Sichuan, China
The Second Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiangweiwuerzizhiqu, 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
Nanshi Hospital of Nanyang
🇨🇳Nanyang, Henan, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
The People's Hospital of Liao Ning Province
🇨🇳Shenyang, Liaoning, China
The Fouth Affiliated Hospital of China Mdical University
🇨🇳Shenyang, Liaoning, China
The First Affiliated Hospital Of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second People's Hospital of Yibin
🇨🇳Yibin, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical
🇨🇳Urumqi, Xinjiang, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Beijing Hospital
🇨🇳Beijing, China
Shang Hai Chest Hospital Shanghai JiaoTong University
🇨🇳Shanghai, China