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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

Sponsor
Zensun Sci. & Tech. Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05949801
Collaborator
(none)
198
Enrollment
80
Locations
2
Arms
16.7
Anticipated Duration (Months)
2.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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:

  1. Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2 ;

  2. Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2 ;

  3. Change from baseline in LVEF, LVESV, LVEDV, LVESVI and LVEDVI at 35 days ;

  4. 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 ;

  5. Change from baseline in LVEF, LVESV, LVEDV, LVESVI and LVEDVI at 90 days ;

  6. Change from baseline in NYHA at 35 and 90 days ;

  7. Change from baseline in quality of life at 35 and 90 days ;

  8. Mortality during the study period.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
198 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical TrialA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking:
Double (Participant, Investigator)
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 13, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Investigational drug group

Neucardin+standard basic therapeutic medication

Drug: Neucardin
10 days IV infusion of 0.6 ug/kg/day
Other Names:
  • Recombinant human Neuregulin-1 for Injection

    		•
    Placebo Comparator: placebo group

    Placebo + standard basic therapeutic medication

    Drug: Placebo
    10 days IV infusion of 0 ug/kg/day
    Other Names:
  • Excipients of recombinant human neuregulin-1 freeze dried for injection

    		•

    Outcome Measures

    Primary Outcome Measures

    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) [Day 35]

      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

    1. Response rate at 35 day of left ventricular end systolic volume index (LVESVI) improvement greater than or equal to 25 ml/m2; [Day 35]

      Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2;

    2. Response rate at 35 day of left ventricular end diastolic volume index (LVEDVI) improvement greater than or equal to 25 ml/m2; [Day 35]

      Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2;

    3. Change from baseline in left ventricular ejection fraction (LVEF) at 35 days; [Day 35]

      Change from baseline in LVEF at 35 days;

    4. Change from baseline in left ventricular end systolic volume (LVESV) at 35 days; [Day 35]

      Change from baseline in LVESV at 35 days;

    5. Change from baseline in left ventricular end diastolic volume (LVEDV) at 35 days; [Day 35]

      Change from baseline in LVEDV at 35 days;

    6. Change from baseline in LVESVI and LVEDVI at 35 days; [Day 35]

      Change from baseline in LVESVI and LVEDVI at 35 days;

    7. 90-day response rate of LVESVI improved greater than or equal to 25 ml/m2; [Day 90]

      90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;

    8. 90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2; [Day 90]

      90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;

    9. 90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time; [Day 90]

      90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;

    10. Change from baseline in LVEF at 90 days; [Day 90]

      Change from baseline in LVEF at 90 days;

    11. Change from baseline in LVESV at 90 days; [Day 90]

      Change from baseline in LVESV at 90 days;

    12. Change from baseline in LVEDV at 90 days; [Day 90]

      Change from baseline in LVEDV at 90 days;

    13. Change from baseline in LVESVI and LVEDVI at 90 days; [Day 90]

      Change from baseline in LVESVI and LVEDVI at 90 days;

    14. Change from baseline in New York Heart Association (NYHA) at 35 and 90 days; [Day 35 and Day 90]

      Change from baseline in NYHA at 35 and 90 days;

    15. Change from baseline in quality of life at 35 and 90 days; [Day 35 and Day 90]

      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.

    16. Mortality during the study period; [Through study completion, an estimation of average of 1 year]

      Mortality during the study period;

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 18-75 years, male or female;

    2. 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);

    3. NT-proBNP ≤1700 pg/ml in males and ≤4000pg/ml in females (detected by Roche kit in central laboratory);

    4. 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;

    5. Understand and sign the informed consent form.

    Exclusion Criteria:

    1. 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;

    2. 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;

    3. 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);

    4. LVESVi less than 135 ml/m2 at baseline;

    5. Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months;

    6. History of heart transplantation, use of ventricular assist devices (VADs) or preparation for heart transplantation, VADs;

    7. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months;

    8. 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);

    9. Angina pectoris within the past 3 months;

    10. Myocardial infarction, cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months;

    11. Serious ventricular arrhythmias (sustained ventricular tachycardia or other conditions that the investigator considers necessary to exclude);

    12. 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);

    13. 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;

    14. Systolic blood pressure < 90 mmHg or > 160 mmHg;

    15. Serum K + < 3.2 mmol/L or > 5.5 mmol/L;

    16. 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;

    17. 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;

    18. The investigator judges that the survival time is expected to be less than 6 months;

    19. Participated in any drug clinical trials within the first 3 months;

    20. Severe neurological disease (Alzheimer's disease, progressive parkinsonism);

    21. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Chao-Yang Hospital , Capital Medical University Beijing Beijing China 100037
    2 Beijing Anzhen Hospital , Capital Medical University Beijing Beijing China
    3 Beijing Friendship Hospital , Capital Medical University Beijing Beijing China
    4 Peking University First Hospital Beijing Beijing China
    5 Peking University People's Hospital Beijing Beijing China
    6 The First Medical Center of General Hospital of Chinese People's Liberation Army Beijing Beijing China
    7 Fuwai Hospital Chinese Academy of Medical Sciences Beijin Beijing China 100037
    8 Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital) Chongqing Chongqing China
    9 Chongqing University Three Gorges Hospital Chongqing Chongqing China
    10 Longyan First Hospital Longyan Fujian China
    11 Xiamen University Affiliated Cardiovascular Hospital Xiamen Fujian China
    12 First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong China
    13 Guangdong Jieyang People's Hospital Jieyang Guangdong China
    14 Liuzhou worker's hospital Liuzhou Guangxi Zhuang Autonomous Region China
    15 People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi Zhuang Autonomous Region China
    16 Haikou People's Hospital Haikou Hainan China
    17 Hainan Provincial People's Hospital Haikou Hainan China
    18 Affiliated Hospital of Hebei University Baoding Hebei China
    19 The First Hospital of Hebei Medical University Shijiazhuang Hebei China
    20 Daqing Oilfield General Hospital Daqing Heilongjiang China
    21 The First Affiliated Hospital of Harbin Medical University Ha'erbin Heilongjiang China
    22 Anyang People's Hospital (Anyang Central Hospital) Anyang Henan China
    23 Huaihe Hospital of Henan University Kaifeng Henan China
    24 First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan China
    25 Luoyang Central Hospital Luoyang Henan China
    26 Nanyang Central Hospital Nanyang Henan China
    27 Nanyang First People's Hospital Nanyang Henan China
    28 General Hospital of Puyang Oilfield Puyang Henan China
    29 Sanmenxia Central Hospital Sanmenxia Henan China
    30 First People's Hospital of Shangqiu Shangqiu Henan China
    31 The First Affiliated Hospital of Xinxiang Medical College Xinxiang Henan China
    32 First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
    33 Chenzhou First People's Hospital Chenzhou Huanan China
    34 People's Hospital of Wuhan University Wuhan Hubei China
    35 Zhongnan Hospital of Wuhan University Wuhan Hubei China
    36 Xiangyang Central Hospital Xiangyang Hubei China
    37 People's Hospital of Hunan Provincial Changsha Hunan China
    38 South China University Affiliated South China Hospital Hengyang Hunan China
    39 The Second Affiliated Hospital of Nanhua University Hengyang Hunan China
    40 Yueyang Central Hospital Yueyang Hunan China
    41 Jiangxi Provincial People's Hospital Nanchang Jiangxi China
    42 Changzhou No.2 People's Hospital Changzhou Jiansu China
    43 Huai'an First People's Hospital Huai'an Jiansu China
    44 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiansu China
    45 Zhongda Hospital Southeast University Nanjing Jiansu China
    46 The First Affiliated Hospital of Soochow University Suzhou Jiansu China
    47 Affiliated Hospital of Xuzhou Medical University Xuzhou Jiansu China
    48 China-Japan Union Hospital of Jilin University Changchun Jilin China
    49 Jilin University Second Hospital Changchun Jilin China
    50 The First Hospital of Jilin University Changchun Jilin China
    51 Benxi Central Hospital Benxi Liaoning China
    52 The First Affiliated Hospital of Dalian Medical University Dalian Liaoning China
    53 Zhongshan Hospital Affiliated to Dalian University Dalian Liaoning China
    54 Shengjing Hospital of China Medical University Shenyang Liaoning China
    55 The First Hospital of China Medical University Shenyang Liaoning China
    56 Heze Municipal Hospital Heze Shandong China
    57 Jinan Central Hospital Jinan Shandong China
    58 Qilu Hospital of Shandong University Jinan Shandong China
    59 Shandong Province Qianfoshan Hospital Jinan Shandong China
    60 Linyi People's Hospital Linyi Shandong China
    61 Tai'an City Central Hospital Tai'an Shandong China
    62 Zibo Municipal Hospital Zibo Shandong China
    63 Putuo District Central Hospital of Shanghai Shanghai Shanghai China
    64 Shanxi Provincial Cardiovascular Hospital Taiyuan Shanxi China
    65 The First Hospital of Shanxi Medical University Taiyuan Shanxi China
    66 The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shanxi China
    67 Xi'an Gaoxin Hospital Xi'an Shanxi China
    68 Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine Xianyang Shanxi China
    69 Xianyang Hospital of Yan 'an University Xianyang Shanxi China
    70 Mianyang Central Hospital Mianyang Sichuan China
    71 The First Affiliated Hospital of Dali University Dali Yunnan China
    72 Fuwai Yunnan Cardiovascular Hospital Kunming Yunnan China
    73 The First People's Hospital of Yunnan Province Kunming Yunnan China
    74 The First Affiliated Hospital , Zhejiang University School of Medicine Hangzhou Zhejiang China
    75 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China
    76 Affiliated Hospital of Hangzhou Normal University Hanzhou Zhejiang China
    77 Sir Run Run Shaw Hospital Hanzhou Zhejiang China
    78 Jiaxing First Hospital Jiaxing Zhejiang China
    79 Ningbo Huamei Hospital, University of Chinese Academy of Sciences (Ningbo Second Hospital) Ningbo Zhejiang China
    80 The First Hospital of Ningbo Ningbo Zhejiang China

    Sponsors and Collaborators

    • Zensun Sci. & Tech. Co., Ltd.

    Investigators

    • Principal Investigator: Jian Zhang, M.D, Chinese Academy of Medical Sciences, Fuwai Hospital
    • Principal Investigator: Mulei Chen, M.D, Beijing Chaoyang Hospital affiliated to Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zensun Sci. & Tech. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05949801
    Other Study ID Numbers:
    • ZS-01-308B
    First Posted:
    Jul 18, 2023
    Last Update Posted:
    Jul 18, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zensun Sci. & Tech. Co., Ltd.
    CHF Neucardin
    Additional relevant MeSH terms:
    Heart Failure
    Heart Failure, Systolic
    Systolic Murmurs
    Ventricular Remodeling

    Study Results

    No Results Posted as of Jul 18, 2023