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

February 27, 2018 updated by: China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients whose NT - proBNP level reduce more than 30% compared to pre-treatment.
Time Frame: 0, 7 days
0, 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Decrease rate in NT-proBNP compared to pre-treatment.
Time Frame: 0, 7 days.
0, 7 days.
Decrease value in NT-proBNP compared to pre-treatment.
Time Frame: 0, 7 days.
0, 7 days.
Likert rating scale of Dyspnoea.
Time Frame: 0, 7 days.
0, 7 days.
The results of Transthoracic Doppler-echocardiography .
Time Frame: 0, 7 days.
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.
Time Frame: 0, 7 days.
0, 7 days.
Composite endpoints.
Time Frame: 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.
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.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiefu Yang, Beijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1312-Z-SHFU-ZS-RE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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