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.

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

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure
• Intervention / Treatment: Drug: Shenfu Zhusheye; Drug: 5% glucose injection

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Chinese PLA General Hospital
  • Beijing, China, 100730
    • Beijing Hospital
  • Shanghai, China, 200030
    • Shang Hai Chest Hospital Shanghai JiaoTong University
  • Anhui
    • Hefei, Anhui, China, 230001
      • An Hui Provincial Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518033
      • The Fourth People's Hospital of Shenzhen（Futian Hospital）
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163000
      • Daqing peoples hospital
  • Henan
    • Nanyang, Henan, China, 473000
      • Nanshi Hospital of Nanyang
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221009
      • Xuzhou Central Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110032
      • The Fouth Affiliated Hospital of China Mdical University
    • Shenyang, Liaoning, China, 110032
      • The People's Hospital of Liao Ning Province
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Tongren Hospital Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Luzhou, Sichuan, China, 646000
      • Hospital (T.C.M.) Affiliated to Sichuan Medical
    • Yibin, Sichuan, China, 644000
      • The Second People's Hospital of Yibin
  • XIjiangweiwuerzizhiqu
    • Shihezi, XIjiangweiwuerzizhiqu, China, 832000
      • The First Affiliated Hospital of the Medical College,Shihezi University
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • The First Affiliated Hospital of Xinjiang Medical
  • Xinjiangweiwuerzizhiqu
    • Ürümqi, Xinjiangweiwuerzizhiqu, China, 830000
      • The Second Affiliated Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310012
      • Tongde Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shenfu Zhusheye; 80 ml Shenfu Zhusheye + 70 ml 5% glucose injection, ivdrip, once a day for 7 days.	Drug: Shenfu Zhusheye; Drug: 5% glucose injection
Placebo Comparator: 5% glucose injection; 150 ml 5% glucose injection, ivdrip, once a day for 7 days.	Drug: 5% glucose injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.	0, 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	Left ventricular ejection fraction (LVEF) and Left Ventricular Diastolic End Diameter (LVDED) will be measured with Transthoracic Doppler-echocardiography.	0, 7 days.
Heart function grade of NYHA.		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.	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.		Adverse event reports will be assessed during medication period and 28 days after medication. Clinical laboratory tests will be assessed at 0, 7 days.

Collaborators and Investigators

• Sponsor: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jiefu Yang, Beijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2014
• Primary Completion (Actual): March 24, 2017
• Study Completion (Actual): March 24, 2017

Study Registration Dates

• First Submitted: April 22, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1312-Z-SHFU-ZS-RE