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A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure

Primary Purpose

Acute Heart Failure

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Shenfu Zhusheye
5% glucose injection
Sponsored by
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • An Hui Provincial Hospital
  • Fujian Provincial Hospital
  • The First Affiliated Hospital, Sun Yat-sen University
  • The Fourth People's Hospital of Shenzhen（Futian Hospital）
  • Daqing peoples hospital
  • Nanshi Hospital of Nanyang
  • The First Affiliated Hospital of Zhengzhou University
  • Xiangya Hospital Central South University
  • Xuzhou Central Hospital
  • Jiangxi Provincial People's Hospital
  • The First Hospital of Jilin University
  • The Fouth Affiliated Hospital of China Mdical University
  • The People's Hospital of Liao Ning Province
  • Tongren Hospital Shanghai Jiao Tong University School Of Medicine
  • The First Affiliated Hospital Of Xi'an Jiaotong University
  • West China Hospital of Sichuan University
  • Hospital (T.C.M.) Affiliated to Sichuan Medical
  • The Second People's Hospital of Yibin
  • The First Affiliated Hospital of the Medical College,Shihezi University
  • The Second Affiliated Hospital of Xinjiang Medical University
  • The First Affiliated Hospital of Xinjiang Medical
  • Tongde hospital of Zhejiang Province
  • Beijing Hospital
  • Chinese PLA General Hospital
  • Shang Hai Chest Hospital Shanghai JiaoTong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Shenfu Zhusheye

5% glucose injection

Arm Description

80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.

150 ml 5% glucose injection, ivdrip, once a day for 7 days.

Outcomes

Primary Outcome Measures

Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.

Secondary Outcome Measures

Decrease rate in NT-proBNP compared to pre-treatment.
Decrease value in NT-proBNP compared to pre-treatment.
Likert rating scale of Dyspnoea.
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.
Heart function grade of NYHA.
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.
Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, electrocardiogram.

Full Information

First Posted
April 22, 2014
Last Updated
February 27, 2018
Sponsor
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02135835
Brief Title
A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
Official Title
A Multicentre, Parallel-Group, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2014 (Actual)
Primary Completion Date
March 24, 2017 (Actual)
Study Completion Date
March 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Shenfu Zhusheye in patients with acute heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shenfu Zhusheye
Arm Type
Experimental
Arm Description
80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.
Arm Title
5% glucose injection
Arm Type
Placebo Comparator
Arm Description
150 ml 5% glucose injection, ivdrip, once a day for 7 days.
Intervention Type
Drug
Intervention Name(s)
Shenfu Zhusheye
Intervention Type
Drug
Intervention Name(s)
5% glucose injection
Primary Outcome Measure Information:
Title
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
Time Frame
0, 7 days
Secondary Outcome Measure Information:
Title
Decrease rate in NT-proBNP compared to pre-treatment.
Time Frame
0, 7 days.
Title
Decrease value in NT-proBNP compared to pre-treatment.
Time Frame
0, 7 days.
Title
Likert rating scale of Dyspnoea.
Time Frame
0, 7 days.
Title
The results of Transthoracic Doppler-echocardiography .
Description
Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography.
Time Frame
0, 7 days.
Title
Heart function grade of NYHA.
Time Frame
0, 7 days.
Title
Composite endpoints.
Description
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiefu Yang
Organizational Affiliation
Beijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
An Hui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Fourth People's Hospital of Shenzhen（Futian Hospital）
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518033
Country
China
Facility Name
Daqing peoples hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Facility Name
Nanshi Hospital of Nanyang
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221009
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Fouth Affiliated Hospital of China Mdical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
The People's Hospital of Liao Ning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110032
Country
China
Facility Name
Tongren Hospital Shanghai Jiao Tong University School Of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Hospital (T.C.M.) Affiliated to Sichuan Medical
City
Luzhou
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Facility Name
The Second People's Hospital of Yibin
City
Yibin
State/Province
Sichuan
ZIP/Postal Code
644000
Country
China
Facility Name
The First Affiliated Hospital of the Medical College,Shihezi University
City
Shihezi
State/Province
XIjiangweiwuerzizhiqu
ZIP/Postal Code
832000
Country
China
Facility Name
The Second Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiangweiwuerzizhiqu
ZIP/Postal Code
830000
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Tongde hospital of Zhejiang Province
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310012
Country
China
Facility Name
Beijing Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Shang Hai Chest Hospital Shanghai JiaoTong University
City
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure

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