<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468529</url>
  </required_header>
  <id_info>
    <org_study_id>ZS-01-308</org_study_id>
    <nct_id>NCT04468529</nct_id>
  </id_info>
  <brief_title>Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure on Standard Heart Failure Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zensun Sci. &amp; Tech. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zensun Sci. &amp; Tech. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to&#xD;
      evaluate the effect of injectable Neucardin on the heart function in male patients with&#xD;
      NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml, NYHA II-III chronic&#xD;
      systolic heart failure, and to confirm its efficacy and safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is planned to be conducted simultaneously in multiple domestic clinical research&#xD;
      site, and a total of 140 subjects will be enrolled, including 70 subjects in the&#xD;
      investigational drug group and 70 subjects in the placebo group.&#xD;
&#xD;
      Primary endpoint: LVESVI change from baseline on day 30 Secondary endpoints: LVEF Change from&#xD;
      baseline on day 30 and day 90. LVESV, LVEDV, LVEDVI change from baseline on day 30. LVESV,&#xD;
      LVESVI, LVEDV, LVEDVI change from baseline on day 90. NT-proBNP change from baseline on day&#xD;
      30 and day 90. NYHA class change from baseline on day 30 and day 90.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 10, 2020</start_date>
  <completion_date type="Anticipated">May 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a multi-center, randomized, double-blind, standard therapy based, placebo-controlled parallel study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>It is planned to conduct the study in several domestic clinical research sites at the same time. A total of 140 subjects will be enrolled, including 70 subjects in the investigational drug group and 70 subjects in the control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Ejection Fraction(LVEF) Change from baseline on day 30 and day 90</measure>
    <time_frame>Day 30 and Day 90</time_frame>
    <description>Left Ventricular Ejection Fraction(LVEF) Change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 90</measure>
    <time_frame>Day 90</time_frame>
    <description>Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End-Systolic Volume(LVESV)change from baseline on day 30 and day 90</measure>
    <time_frame>Day 30 and Day 90</time_frame>
    <description>Left Ventricular End-Systolic Volume(LVESV)change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End-Diastolic Volume(LVEDV)change from baseline on day 30 and day 90</measure>
    <time_frame>Day 30 and Day 90</time_frame>
    <description>Left Ventricular End-Diastolic Volume(LVEDV)change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular End-Diastolic Volume Index(LVEDVI )change from baseline on day 30 and day 90</measure>
    <time_frame>Day 30 and Day 90</time_frame>
    <description>Left Ventricular End-Diastolic Volume Index(LVEDVI )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline on day 30 and day 90</measure>
    <time_frame>Day 30 and Day 90</time_frame>
    <description>N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association(NYHA) class change from baseline on day 30 and day 90</measure>
    <time_frame>Day 30 and day 90</time_frame>
    <description>New York Heart Association(NYHA) class change from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Chronic Systolic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Investigational drug group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injectable Neucardin + standard basic therapeutic medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo + standard basic therapeutic medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant human Neuregulin for injection</intervention_name>
    <description>10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)</description>
    <arm_group_label>Investigational drug group</arm_group_label>
    <other_name>Neucardin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>10 hours per day i.v. drip for the first 10 days (0ug/kg/day)</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-75 years, male or female;&#xD;
&#xD;
          2. Confirmed diagnosis of heart failure, in stable condition currently, NYHA class&#xD;
             II-III, left ventricular ejection fraction (LVEF)≤40% (measured by echocardiography&#xD;
             with modified Simpson's method at Screening 1, and measured by CMR at Screening 2 and&#xD;
             baseline);&#xD;
&#xD;
          3. Male NT-proBNP ≤1700 pg/ml or female NT-proBNP≤4000 pg/ml (detected by Roche kit in&#xD;
             the central laboratory at screening 1);&#xD;
&#xD;
          4. Receiving standard basic therapeutic medication for heart failure for more than 3&#xD;
             months, at the target dose or maximum tolerated dose for more than 1 month, or no&#xD;
             change in dose within the last 1 month;&#xD;
&#xD;
          5. Understand and sign the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Atrial fibrillation during the screening period;&#xD;
&#xD;
          2. Conditions limiting CMR examination, such as installation of pacemakers, ICDs, CRTs or&#xD;
             other similar devices contraindicated for CMR, or have claustrophobia;&#xD;
&#xD;
          3. Hypertrophic cardiomyopathy with outflow tract obstruction, constrictive pericarditis,&#xD;
             significant and uncorrected valvular heart disease (severe regurgitation or severe&#xD;
             stenosis or valvular disease requiring surgery), congenital heart disease requiring&#xD;
             surgery but not yet undergoing surgical treatment, primary pulmonary hypertension or&#xD;
             secondary severe pulmonary hypertension (≥ 70 mmHg);&#xD;
&#xD;
          4. Right heart failure due to lung disease;&#xD;
&#xD;
          5. Subjects with chronic heart failure complicated with acute hemodynamic disturbance or&#xD;
             acute decompensation within recent 1 month (symptoms and signs indicate chronic heart&#xD;
             failure is aggravated, and intravenous drug therapy may be required);&#xD;
&#xD;
          6. Angina pectoris within 3 months;&#xD;
&#xD;
          7. Myocardial infarction within the past 6 months;&#xD;
&#xD;
          8. Cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery,&#xD;
             carotid artery or other large vessel surgery within the past 6 months;&#xD;
&#xD;
          9. Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months;&#xD;
&#xD;
         10. History of heart transplantation, use of ventricular assist device (VAD) or&#xD;
             preparation for heart transplantation, VAD;&#xD;
&#xD;
         11. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12&#xD;
             months;&#xD;
&#xD;
         12. Serious arrhythmia (sustained ventricular tachycardia or other conditions meet the&#xD;
             criteria according to the investigator's judgement );&#xD;
&#xD;
         13. Clinical diagnosis of pericardial effusion, pleural effusion or B ultrasound showed&#xD;
             pericardial effusion (greater than 50ml or 3 mm) or pleural effusion (greater than&#xD;
             200ml or 10 mm);&#xD;
&#xD;
         14. Liver or kidney dysfunction, chronic liver disease may have a potential impact on&#xD;
             liver function, non-heart failure induced bilirubin or alkaline phosphatase &gt; 2 times&#xD;
             the upper limit of normal, aspartate aminotransferase or alanine aminotransferase &gt; 3&#xD;
             times the upper limit of normal, eGFR calculated using the MDRD method &lt; 30&#xD;
             ml/min/1.73m2 ;&#xD;
&#xD;
         15. Systolic blood pressure &lt; 90 mmHg or &gt; 160 mmHg;&#xD;
&#xD;
         16. Blood K + &lt; 3.2 mmol/L or &gt; 5.5 mmol/L;&#xD;
&#xD;
         17. Subjects with an absolute change in LVEF &gt; 5% as detected by CMR between screening 2&#xD;
             and baseline;&#xD;
&#xD;
         18. Women of childbearing age who are planning to become pregnant within 2 years (women of&#xD;
             childbearing age are defined as all women with physiological capability to become&#xD;
             pregnant), and pregnant or lactating women;&#xD;
&#xD;
         19. Patients whose survival time is expected to be less than 6 months as judged by the&#xD;
             investigator;&#xD;
&#xD;
         20. Those who have participated in any drug clinical trial within the previous 3 months;&#xD;
&#xD;
         21. Severe neurological disorders (Alzheimer's disease, progressive parkinsonism);&#xD;
&#xD;
         22. The subjects with tumor history or is suffering from tumor now, or with precancerous&#xD;
             lesions confirmed by pathological examination (such as breast ductal carcinoma in&#xD;
             situ, or cervical dysplasia), or with malignant mass found by examination (physical&#xD;
             examination, X-ray examination or B ultrasound examination or other means);&#xD;
&#xD;
         23. The subjects with proliferative glands or adenomas that are found to have endocrine&#xD;
             activity that affects cardiac function or endocrine function detected by examinations&#xD;
             (physical examination, X-ray examination, B ultrasound examination or other means),&#xD;
             such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid or normal&#xD;
             thyroid function do not need to be excluded);&#xD;
&#xD;
         24. The subject, in the judgment of the Investigator, is unable to complete the study or&#xD;
             to comply with the requirements of the study (for administrative or other reasons).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinchun Yang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aidong Shen, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Dong, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huaming Mou, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chongqing Three Gorges Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fanbo Meng, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>China-Japan Union Hospital, Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yushi Wang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ying Liu, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Dalian Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zongjun Liu, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Putuo District Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaowen Liu, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tingbo Jiang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Suzhou Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guohai Su, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jinan Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming Zhong, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital of Shandong University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gangqiong Liu, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Zhengzhou University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yinglong Hou, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qianfoshan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ping Qiao, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hainan General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shijuan Lu, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haikou People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shumei Ma, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shengjing Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shouyan Zhang, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Luoyang Central Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianqiang Peng, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hunan Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yugang Dong, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital, Zhongshan University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huanzhen Chen, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Shanxi Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huiyuan Han, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanxi Cardiovascular Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mulei Chen, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chongqing Three Gorges Central Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haikou People's Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Failure, Systolic</mesh_term>
    <mesh_term>Systolic Murmurs</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Zensun ensures that the key information about the design of this protocol will be published in a publicly available database such as www.clinicaltrials.gov. After the end of the trial, Zensun will assist the study site to objectively summarize the trial results, use appropriate statistical methods to analyze the trial data, objectively evaluate the safety and efficacy of the drug according to the results, and make a complete written summary report of the clinical trial. Study results will be submitted for publication and/or publication in a publicly available database. If other individuals or institutions related to this study want to publish or publish the study results or related data, they need to obtain the consent of the sponsor in advance. If the sponsor needs to include the name of the investigators in any publication or advertisement, the consent of the investigator should be obtained.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468529
org study id: ZS-01-308
nct id: NCT04468529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multi-center, randomized, double-blind, placebo-controlled phase III clinical trial to
      evaluate the effect of injectable Neucardin on the heart function in male patients with
      NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml, NYHA II-III chronic
      systolic heart failure, and to confirm its efficacy and safety.
This trial is planned to be conducted simultaneously in multiple domestic clinical research
      site, and a total of 140 subjects will be enrolled, including 70 subjects in the
      investigational drug group and 70 subjects in the placebo group.

      Primary endpoint: LVESVI change from baseline on day 30 Secondary endpoints: LVEF Change from
      baseline on day 30 and day 90. LVESV, LVEDV, LVEDVI change from baseline on day 30. LVESV,
      LVESVI, LVEDV, LVEDVI change from baseline on day 90. NT-proBNP change from baseline on day
      30 and day 90. NYHA class change from baseline on day 30 and day 90.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a multi-center, randomized, double-blind, standard therapy based, placebo-controlled parallel study.
primary purpose: Treatment
masking: Single (Participant)
masking description: It is planned to conduct the study in several domestic clinical research sites at the same time. A total of 140 subjects will be enrolled, including 70 subjects in the investigational drug group and 70 subjects in the control group.
measure: Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 30
time frame: Day 30
description: Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline
measure: Left Ventricular Ejection Fraction(LVEF) Change from baseline on day 30 and day 90
time frame: Day 30 and Day 90
description: Left Ventricular Ejection Fraction(LVEF) Change from baseline
measure: Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 90
time frame: Day 90
description: Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline
measure: Left Ventricular End-Systolic Volume(LVESV)change from baseline on day 30 and day 90
time frame: Day 30 and Day 90
description: Left Ventricular End-Systolic Volume(LVESV)change from baseline
measure: Left Ventricular End-Diastolic Volume(LVEDV)change from baseline on day 30 and day 90
time frame: Day 30 and Day 90
description: Left Ventricular End-Diastolic Volume(LVEDV)change from baseline
measure: Left Ventricular End-Diastolic Volume Index(LVEDVI )change from baseline on day 30 and day 90
time frame: Day 30 and Day 90
description: Left Ventricular End-Diastolic Volume Index(LVEDVI )
measure: N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline on day 30 and day 90
time frame: Day 30 and Day 90
description: N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline
measure: New York Heart Association(NYHA) class change from baseline on day 30 and day 90
time frame: Day 30 and day 90
description: New York Heart Association(NYHA) class change from baseline
arm group label: Investigational drug group
arm group type: Experimental
description: Injectable Neucardin + standard basic therapeutic medication
arm group label: Placebo group
arm group type: Placebo Comparator
description: placebo + standard basic therapeutic medication
intervention type: Drug
intervention name: Recombinant human Neuregulin for injection
description: 10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)
arm group label: Investigational drug group
other name: Neucardin
intervention type: Drug
intervention name: Placebo
description: 10 hours per day i.v. drip for the first 10 days (0ug/kg/day)
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xinchun Yang, M.D
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: Aidong Shen, M.D
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Wei Dong, M.D
role: Principal Investigator
affiliation: Chinese PLA General Hospital
last name: Huaming Mou, M.D
role: Principal Investigator
affiliation: Chongqing Three Gorges Central Hospital
last name: Fanbo Meng, M.D
role: Principal Investigator
affiliation: China-Japan Union Hospital, Jilin University
last name: Yushi Wang, M.D
role: Principal Investigator
affiliation: The First Hospital of Jilin University
last name: Ying Liu, M.D
role: Principal Investigator
affiliation: The First Affiliated Hospital of Dalian Medical University
last name: Zongjun Liu, M.D
role: Principal Investigator
affiliation: Shanghai Putuo District Central Hospital
last name: Shaowen Liu, M.D
role: Principal Investigator
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
last name: Tingbo Jiang, M.D
role: Principal Investigator
affiliation: First Affiliated Hospital of Suzhou Medical College
last name: Guohai Su, M.D
role: Principal Investigator
affiliation: Jinan Central Hospital
last name: Ming Zhong, M.D
role: Principal Investigator
affiliation: Qilu Hospital of Shandong University
last name: Gangqiong Liu, M.D
role: Principal Investigator
affiliation: The First Affiliated Hospital of Zhengzhou University
last name: Yinglong Hou, M.D
role: Principal Investigator
affiliation: Qianfoshan Hospital
last name: Ping Qiao, M.D
role: Principal Investigator
affiliation: Hainan General Hospital
last name: Shijuan Lu, M.D
role: Principal Investigator
affiliation: Haikou People's Hospital
last name: Shumei Ma, M.D
role: Principal Investigator
affiliation: Shengjing Hospital
last name: Shouyan Zhang, M.D
role: Principal Investigator
affiliation: Luoyang Central Hospital
last name: Jianqiang Peng, M.D
role: Principal Investigator
affiliation: Hunan Provincial People's Hospital
last name: Yugang Dong, M.D
role: Principal Investigator
affiliation: The First Affiliated Hospital, Zhongshan University
last name: Huanzhen Chen, M.D
role: Principal Investigator
affiliation: The First Affiliated Hospital of Shanxi Medical University
last name: Huiyuan Han, M.D
role: Principal Investigator
affiliation: Shanxi Cardiovascular Hospital
last name: Mulei Chen, M.D
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Failure, Systolic
mesh term: Systolic Murmurs
sharing ipd: No
ipd description: Zensun ensures that the key information about the design of this protocol will be published in a publicly available database such as www.clinicaltrials.gov. After the end of the trial, Zensun will assist the study site to objectively summarize the trial results, use appropriate statistical methods to analyze the trial data, objectively evaluate the safety and efficacy of the drug according to the results, and make a complete written summary report of the clinical trial. Study results will be submitted for publication and/or publication in a publicly available database. If other individuals or institutions related to this study want to publish or publish the study results or related data, they need to obtain the consent of the sponsor in advance. If the sponsor needs to include the name of the investigators in any publication or advertisement, the consent of the investigator should be obtained.