A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
A Multicentre, Parallel-Group, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure.
1 other identifier
interventional
365
1 country
25
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2014
Typical duration for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
May 12, 2014
CompletedStudy Start
First participant enrolled
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2017
CompletedMarch 1, 2018
January 1, 2018
2.6 years
April 22, 2014
February 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
0, 7 days
Secondary Outcomes (7)
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.
Heart function grade of NYHA.
0, 7 days.
- +2 more secondary outcomes
Study Arms (2)
Shenfu Zhusheye
EXPERIMENTAL80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.
5% glucose injection
PLACEBO COMPARATOR150 ml 5% glucose injection, ivdrip, once a day for 7 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
An Hui Provincial Hospital
Hefei, Anhui, 230001, China
Fujian Provincial Hospital
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiefu Yang
Beijing Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2014
First Posted
May 12, 2014
Study Start
September 3, 2014
Primary Completion
March 24, 2017
Study Completion
March 24, 2017
Last Updated
March 1, 2018
Record last verified: 2018-01