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Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure

Primary Purpose

Chronic Systolic Heart Failure

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Neucardin
Placebo
Sponsored by
Zensun Sci. & Tech. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Systolic Heart Failure focused on measuring CHF Neucardin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-75 years, male or female; Definite diagnosis of heart failure for 6 months or more, current stable disease, NYHA class II-III, left ventricular ejection fraction (LVEF) ≤ 40%(echocardiographic modified Simpson's method measurement ≤ 40% at screening, and CMR measurement ≤ 40% at baseline); NT-proBNP ≤1700 pg/ml in males and ≤4000pg/ml in females (detected by Roche kit in central laboratory); Receiving standard basic treatment for heart failure for at least 3 months, and did not change the type and dose of heart failure treatment drugs within 1 month; Understand and sign the informed consent form. Exclusion Criteria: Unable to receive CMR examination, such as patients with pacemakers, ICDs, CRTs, or other similar devices contraindicated for CMR, claustrophobia, atrial fibrillation during the screening period, or inability to cooperate with air-closed activities required for CMR testing; Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, constrictive pericarditis, significant and uncorrected valvular heart disease, severe valvular regurgitation or severe stenosis, congenital heart disease requiring surgical treatment but not surgical treatment, primary pulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg), and right heart failure due to pulmonary disease; Patients suffering from proliferative glands or adenomas with endocrine activity which may affect cardiac function or endocrine function, such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid nodules do not need to be excluded); LVESVi less than 135 ml/m2 at baseline; Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months; History of heart transplantation, use of ventricular assist devices (VADs) or preparation for heart transplantation, VADs; Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months; Subjects with chronic heart failure with acute hemodynamic disturbance or acute decompensation within the past 1 month (symptoms and signs prove that chronic heart failure is aggravated and intravenous drug therapy is required); Angina pectoris within the past 3 months; Myocardial infarction, cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months; Serious ventricular arrhythmias (sustained ventricular tachycardia or other conditions that the investigator considers necessary to exclude); Clinical diagnosis of pericardial effusion, pleural effusion or imaging showed pericardial effusion (greater than 50ml or 3 mm or a small amount or more) or pleural effusion (greater than 200ml or 10 mm); Liver and kidney dysfunction and chronic liver disease may have a potential impact on liver function (such as active chronic hepatitis, etc.), non-heart failure causes of bilirubin or alkaline phosphatase > 2 times the upper limit of normal, aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal, eGFR calculated using MDRD method < 30 ml/min/1.73 m2; Systolic blood pressure < 90 mmHg or > 160 mmHg; Serum K + < 3.2 mmol/L or > 5.5 mmol/L; Women of childbearing potential who plan to become pregnant within 2 years (women of childbearing potential are defined as all women with physical ability to become pregnant), pregnant or lactating women; Previous history of cancer or current cancer, or pathological examination confirmed precancerous lesions (Such as ductal carcinoma in situ of the breast, or atypical hyperplasia of the cervix), or through the examination (physical examination, X-ray examination or B ultrasound examination or other means) found in vivo malignant mass subjects; The investigator judges that the survival time is expected to be less than 6 months; Participated in any drug clinical trials within the first 3 months; Severe neurological disease (Alzheimer's disease, progressive parkinsonism); Subjects who are unable to complete this study or fail to comply with the requirements of this study (due to administrative reasons or other reasons), as judged by the investigator.

Sites / Locations

  • Beijing Chao-Yang Hospital , Capital Medical University
  • Beijing Anzhen Hospital , Capital Medical University
  • Beijing Friendship Hospital , Capital Medical University
  • Peking University First Hospital
  • Peking University People's Hospital
  • The First Medical Center of General Hospital of Chinese People's Liberation Army
  • Fuwai Hospital Chinese Academy of Medical Sciences
  • Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital)
  • Chongqing University Three Gorges Hospital
  • Longyan First Hospital
  • Xiamen University Affiliated Cardiovascular Hospital
  • First Affiliated Hospital of Sun Yat-sen University
  • Guangdong Jieyang People's Hospital
  • Liuzhou worker's hospital
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • Haikou People's Hospital
  • Hainan Provincial People's Hospital
  • Affiliated Hospital of Hebei University
  • The First Hospital of Hebei Medical University
  • Daqing Oilfield General Hospital
  • The First Affiliated Hospital of Harbin Medical University
  • Anyang People's Hospital (Anyang Central Hospital)
  • Huaihe Hospital of Henan University
  • First Affiliated Hospital of Henan University of Science and Technology
  • Luoyang Central Hospital
  • Nanyang Central HospitalRecruiting
  • Nanyang First People's Hospital
  • General Hospital of Puyang Oilfield
  • Sanmenxia Central Hospital
  • First People's Hospital of Shangqiu
  • The First Affiliated Hospital of Xinxiang Medical College
  • First Affiliated Hospital of Zhengzhou University
  • Chenzhou First People's Hospital
  • People's Hospital of Wuhan University
  • Zhongnan Hospital of Wuhan University
  • Xiangyang Central Hospital
  • People's Hospital of Hunan Provincial
  • South China University Affiliated South China Hospital
  • The Second Affiliated Hospital of Nanhua University
  • Yueyang Central Hospital
  • Jiangxi Provincial People's Hospital
  • Changzhou No.2 People's HospitalRecruiting
  • Huai'an First People's Hospital
  • The Second Affiliated Hospital of Nanjing Medical University
  • Zhongda Hospital Southeast University
  • The First Affiliated Hospital of Soochow University
  • Affiliated Hospital of Xuzhou Medical University
  • China-Japan Union Hospital of Jilin University
  • Jilin University Second Hospital
  • The First Hospital of Jilin University
  • Benxi Central Hospital
  • The First Affiliated Hospital of Dalian Medical University
  • Zhongshan Hospital Affiliated to Dalian University
  • Shengjing Hospital of China Medical University
  • The First Hospital of China Medical University
  • Heze Municipal Hospital
  • Jinan Central Hospital
  • Qilu Hospital of Shandong University
  • Shandong Province Qianfoshan Hospital
  • Linyi People's Hospital
  • Tai'an City Central Hospital
  • Zibo Municipal Hospital
  • Putuo District Central Hospital of Shanghai
  • Shanxi Provincial Cardiovascular HospitalRecruiting
  • The First Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Xi 'an Jiaotong University
  • Xi'an Gaoxin Hospital
  • Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
  • Xianyang Hospital of Yan 'an UniversityRecruiting
  • Mianyang Central Hospital
  • The First Affiliated Hospital of Dali University
  • Fuwai Yunnan Cardiovascular Hospital
  • The First People's Hospital of Yunnan Province
  • The First Affiliated Hospital , Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Affiliated Hospital of Hangzhou Normal University
  • Sir Run Run Shaw Hospital
  • Jiaxing First Hospital
  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences (Ningbo Second Hospital)
  • The First Hospital of Ningbo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational drug group

placebo group

Arm Description

Neucardin+standard basic therapeutic medication

Placebo + standard basic therapeutic medication

Outcomes

Primary Outcome Measures

Response rate at 35 days of simultaneous reduction of LVESVI and LVEDVI by more than or equal to 20 ml/m2 (The proportion of the subjects achieving this criterion in each treatment group)
Response rate at 35 days of simultaneous reduction of LVESVI and LVEDVI by more than or equal to 20 ml/m2 (The proportion of the subjects achieving this criterion in each treatment group)

Secondary Outcome Measures

Response rate at 35 day of left ventricular end systolic volume index (LVESVI) improvement greater than or equal to 25 ml/m2;
Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2;
Response rate at 35 day of left ventricular end diastolic volume index (LVEDVI) improvement greater than or equal to 25 ml/m2;
Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2;
Change from baseline in left ventricular ejection fraction (LVEF) at 35 days;
Change from baseline in LVEF at 35 days;
Change from baseline in left ventricular end systolic volume (LVESV) at 35 days;
Change from baseline in LVESV at 35 days;
Change from baseline in left ventricular end diastolic volume (LVEDV) at 35 days;
Change from baseline in LVEDV at 35 days;
Change from baseline in LVESVI and LVEDVI at 35 days;
Change from baseline in LVESVI and LVEDVI at 35 days;
90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;
90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;
90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;
90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;
90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;
90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;
Change from baseline in LVEF at 90 days;
Change from baseline in LVEF at 90 days;
Change from baseline in LVESV at 90 days;
Change from baseline in LVESV at 90 days;
Change from baseline in LVEDV at 90 days;
Change from baseline in LVEDV at 90 days;
Change from baseline in LVESVI and LVEDVI at 90 days;
Change from baseline in LVESVI and LVEDVI at 90 days;
Change from baseline in New York Heart Association (NYHA) at 35 and 90 days;
Change from baseline in NYHA at 35 and 90 days;
Change from baseline in quality of life at 35 and 90 days;
Change from baseline in quality of life at 35 and 90 days;The benefit of patients is reflected by the quality of life score table.
Mortality during the study period;
Mortality during the study period;

Full Information

First Posted
June 2, 2023
Last Updated
July 9, 2023
Sponsor
Zensun Sci. & Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05949801
Brief Title
Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Based on Standard Treatment to Evaluate the Effect of Injectable Neucardin on Cardiac Function and Reverse Ventricular Remodeling in Patients With Chronic Systolic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zensun Sci. & Tech. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of recombinant human Neuregulin-1 for injection on cardiac function and reverse ventricular remodeling in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml and New York Heart Association class II-III chronic systolic heart failure, and to confirm its efficacy and safety.
Detailed Description
This trial is planned to be conducted simultaneously in multiple clinical study sites nationwide, including 198 subjects, 99 subjects in the treatment group and 99 subjects in the placebo group. Primary endpoint: 1.Response rate at 35 days of simultaneous reduction of LVESVI and LVEDVI by more than or equal to 20 ml/m2 (The proportion of the subjects achieving this criterion in each treatment group.) Secondary endpoints: Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2 ; Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2 ; Change from baseline in LVEF, LVESV, LVEDV, LVESVI and LVEDVI at 35 days ; 90-day response rate of LVESVI improved greater than or equal to 25ml/m2,LVEDVI improved greater than or equal to 25 ml/m2, and LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time ; Change from baseline in LVEF, LVESV, LVEDV, LVESVI and LVEDVI at 90 days ; Change from baseline in NYHA at 35 and 90 days ; Change from baseline in quality of life at 35 and 90 days ; Mortality during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Systolic Heart Failure
Keywords
CHF Neucardin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking
ParticipantInvestigator
Masking Description
This trial is planned to be conducted simultaneously in multiple clinical study sites nationwide, including 198 subjects, 99 subjects in the treatment group and 99 subjects in the placebo group.
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational drug group
Arm Type
Experimental
Arm Description
Neucardin+standard basic therapeutic medication
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo + standard basic therapeutic medication
Intervention Type
Drug
Intervention Name(s)
Neucardin
Other Intervention Name(s)
Recombinant human Neuregulin-1 for Injection
Intervention Description
10 days IV infusion of 0.6 ug/kg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Excipients of recombinant human neuregulin-1 freeze dried for injection
Intervention Description
10 days IV infusion of 0 ug/kg/day
Primary Outcome Measure Information:
Title
Response rate at 35 days of simultaneous reduction of LVESVI and LVEDVI by more than or equal to 20 ml/m2 (The proportion of the subjects achieving this criterion in each treatment group)
Description
Response rate at 35 days of simultaneous reduction of LVESVI and LVEDVI by more than or equal to 20 ml/m2 (The proportion of the subjects achieving this criterion in each treatment group)
Time Frame
Day 35
Secondary Outcome Measure Information:
Title
Response rate at 35 day of left ventricular end systolic volume index (LVESVI) improvement greater than or equal to 25 ml/m2;
Description
Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2;
Time Frame
Day 35
Title
Response rate at 35 day of left ventricular end diastolic volume index (LVEDVI) improvement greater than or equal to 25 ml/m2;
Description
Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2;
Time Frame
Day 35
Title
Change from baseline in left ventricular ejection fraction (LVEF) at 35 days;
Description
Change from baseline in LVEF at 35 days;
Time Frame
Day 35
Title
Change from baseline in left ventricular end systolic volume (LVESV) at 35 days;
Description
Change from baseline in LVESV at 35 days;
Time Frame
Day 35
Title
Change from baseline in left ventricular end diastolic volume (LVEDV) at 35 days;
Description
Change from baseline in LVEDV at 35 days;
Time Frame
Day 35
Title
Change from baseline in LVESVI and LVEDVI at 35 days;
Description
Change from baseline in LVESVI and LVEDVI at 35 days;
Time Frame
Day 35
Title
90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;
Description
90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;
Time Frame
Day 90
Title
90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;
Description
90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;
Time Frame
Day 90
Title
90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;
Description
90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;
Time Frame
Day 90
Title
Change from baseline in LVEF at 90 days;
Description
Change from baseline in LVEF at 90 days;
Time Frame
Day 90
Title
Change from baseline in LVESV at 90 days;
Description
Change from baseline in LVESV at 90 days;
Time Frame
Day 90
Title
Change from baseline in LVEDV at 90 days;
Description
Change from baseline in LVEDV at 90 days;
Time Frame
Day 90
Title
Change from baseline in LVESVI and LVEDVI at 90 days;
Description
Change from baseline in LVESVI and LVEDVI at 90 days;
Time Frame
Day 90
Title
Change from baseline in New York Heart Association (NYHA) at 35 and 90 days;
Description
Change from baseline in NYHA at 35 and 90 days;
Time Frame
Day 35 and Day 90
Title
Change from baseline in quality of life at 35 and 90 days;
Description
Change from baseline in quality of life at 35 and 90 days;The benefit of patients is reflected by the quality of life score table.
Time Frame
Day 35 and Day 90
Title
Mortality during the study period;
Description
Mortality during the study period;
Time Frame
Through study completion, an estimation of average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years, male or female; Definite diagnosis of heart failure for 6 months or more, current stable disease, NYHA class II-III, left ventricular ejection fraction (LVEF) ≤ 40%(echocardiographic modified Simpson's method measurement ≤ 40% at screening, and CMR measurement ≤ 40% at baseline); NT-proBNP ≤1700 pg/ml in males and ≤4000pg/ml in females (detected by Roche kit in central laboratory); Receiving standard basic treatment for heart failure for at least 3 months, and did not change the type and dose of heart failure treatment drugs within 1 month; Understand and sign the informed consent form. Exclusion Criteria: Unable to receive CMR examination, such as patients with pacemakers, ICDs, CRTs, or other similar devices contraindicated for CMR, claustrophobia, atrial fibrillation during the screening period, or inability to cooperate with air-closed activities required for CMR testing; Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, constrictive pericarditis, significant and uncorrected valvular heart disease, severe valvular regurgitation or severe stenosis, congenital heart disease requiring surgical treatment but not surgical treatment, primary pulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg), and right heart failure due to pulmonary disease; Patients suffering from proliferative glands or adenomas with endocrine activity which may affect cardiac function or endocrine function, such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid nodules do not need to be excluded); LVESVi less than 135 ml/m2 at baseline; Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months; History of heart transplantation, use of ventricular assist devices (VADs) or preparation for heart transplantation, VADs; Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months; Subjects with chronic heart failure with acute hemodynamic disturbance or acute decompensation within the past 1 month (symptoms and signs prove that chronic heart failure is aggravated and intravenous drug therapy is required); Angina pectoris within the past 3 months; Myocardial infarction, cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months; Serious ventricular arrhythmias (sustained ventricular tachycardia or other conditions that the investigator considers necessary to exclude); Clinical diagnosis of pericardial effusion, pleural effusion or imaging showed pericardial effusion (greater than 50ml or 3 mm or a small amount or more) or pleural effusion (greater than 200ml or 10 mm); Liver and kidney dysfunction and chronic liver disease may have a potential impact on liver function (such as active chronic hepatitis, etc.), non-heart failure causes of bilirubin or alkaline phosphatase > 2 times the upper limit of normal, aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal, eGFR calculated using MDRD method < 30 ml/min/1.73 m2; Systolic blood pressure < 90 mmHg or > 160 mmHg; Serum K + < 3.2 mmol/L or > 5.5 mmol/L; Women of childbearing potential who plan to become pregnant within 2 years (women of childbearing potential are defined as all women with physical ability to become pregnant), pregnant or lactating women; Previous history of cancer or current cancer, or pathological examination confirmed precancerous lesions (Such as ductal carcinoma in situ of the breast, or atypical hyperplasia of the cervix), or through the examination (physical examination, X-ray examination or B ultrasound examination or other means) found in vivo malignant mass subjects; The investigator judges that the survival time is expected to be less than 6 months; Participated in any drug clinical trials within the first 3 months; Severe neurological disease (Alzheimer's disease, progressive parkinsonism); Subjects who are unable to complete this study or fail to comply with the requirements of this study (due to administrative reasons or other reasons), as judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Qin, ph.D
Phone
86-021-50802627
Ext
138
Email
qinxiaoyan@zensun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Siyuan Xu
Phone
86-021-50802627
Ext
207
Email
xusiyuan@zensun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, M.D
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mulei Chen, M.D
Organizational Affiliation
Beijing Chaoyang Hospital affiliated to Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital , Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Anzhen Hospital , Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Friendship Hospital , Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Medical Center of General Hospital of Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fuwai Hospital Chinese Academy of Medical Sciences
City
Beijin
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital)
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chongqing University Three Gorges Hospital
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Longyan First Hospital
City
Longyan
State/Province
Fujian
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiamen University Affiliated Cardiovascular Hospital
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangdong Jieyang People's Hospital
City
Jieyang
State/Province
Guangdong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Liuzhou worker's hospital
City
Liuzhou
State/Province
Guangxi Zhuang Autonomous Region
Country
China
Individual Site Status
Active, not recruiting
Facility Name
People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Haikou People's Hospital
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hainan Provincial People's Hospital
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Daqing Oilfield General Hospital
City
Daqing
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Anyang People's Hospital (Anyang Central Hospital)
City
Anyang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Huaihe Hospital of Henan University
City
Kaifeng
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianbu Gao, M.D
Facility Name
Nanyang First People's Hospital
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
General Hospital of Puyang Oilfield
City
Puyang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sanmenxia Central Hospital
City
Sanmenxia
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First People's Hospital of Shangqiu
City
Shangqiu
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xinxiang Medical College
City
Xinxiang
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Chenzhou First People's Hospital
City
Chenzhou
State/Province
Huanan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
People's Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
People's Hospital of Hunan Provincial
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
South China University Affiliated South China Hospital
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital of Nanhua University
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Yueyang Central Hospital
City
Yueyang
State/Province
Hunan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Ji, M.D
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiansu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiansu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiansu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiansu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiansu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
China-Japan Union Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jilin University Second Hospital
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Benxi Central Hospital
City
Benxi
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhongshan Hospital Affiliated to Dalian University
City
Dalian
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Heze Municipal Hospital
City
Heze
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shandong Province Qianfoshan Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Linyi People's Hospital
City
Linyi
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tai'an City Central Hospital
City
Tai'an
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zibo Municipal Hospital
City
Zibo
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Putuo District Central Hospital of Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanxi Provincial Cardiovascular Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiyuan Han, M.D
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xi'an Gaoxin Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
City
Xianyang
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Xianyang Hospital of Yan 'an University
City
Xianyang
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Zuo, M.D
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Dali University
City
Dali
State/Province
Yunnan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fuwai Yunnan Cardiovascular Hospital
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital , Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Hangzhou Normal University
City
Hanzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sir Run Run Shaw Hospital
City
Hanzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiaxing First Hospital
City
Jiaxing
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Ningbo Huamei Hospital, University of Chinese Academy of Sciences (Ningbo Second Hospital)
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Ningbo
City
Ningbo
State/Province
Zhejiang
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan 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.

Learn more about this trial

Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure

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