Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure

Last updated: July 24, 2024
Sponsor: Zensun Sci. & Tech. Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Congestive Heart Failure

Chest Pain

Heart Failure

Treatment

Recombinant human Neuregulin for injection

Placebo

Clinical Study ID

NCT04468529
ZS-01-308
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18-75 years, male or female;

  2. Confirmed diagnosis of heart failure, in stable condition currently, NYHA classII-III, left ventricular ejection fraction (LVEF)≤40% (measured by echocardiographywith modified Simpson's method at Screening 1, and measured by CMR at Screening 2and baseline);

  3. Male NT-proBNP ≤1700 pg/ml or female NT-proBNP≤4000 pg/ml (detected by Roche kit inthe central laboratory at screening 1);

  4. Receiving standard basic therapeutic medication for heart failure for more than 3months, at the target dose or maximum tolerated dose for more than 1 month, or nochange in dose within the last 1 month;

  5. Understand and sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Atrial fibrillation during the screening period;

  2. Conditions limiting CMR examination, such as installation of pacemakers, ICDs, CRTsor other similar devices contraindicated for CMR, or have claustrophobia;

  3. Hypertrophic cardiomyopathy with outflow tract obstruction, constrictivepericarditis, significant and uncorrected valvular heart disease (severeregurgitation or severe stenosis or valvular disease requiring surgery), congenitalheart disease requiring surgery but not yet undergoing surgical treatment, primarypulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg);

  4. Right heart failure due to lung disease;

  5. Subjects with chronic heart failure complicated with acute hemodynamic disturbanceor acute decompensation within recent 1 month (symptoms and signs indicate chronicheart failure is aggravated, and intravenous drug therapy may be required);

  6. Angina pectoris within 3 months;

  7. Myocardial infarction within the past 6 months;

  8. Cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery,carotid artery or other large vessel surgery within the past 6 months;

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

  10. History of heart transplantation, use of ventricular assist device (VAD) orpreparation for heart transplantation, VAD;

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

  12. Serious arrhythmia (sustained ventricular tachycardia or other conditions meet thecriteria according to the investigator's judgement );

  13. Clinical diagnosis of pericardial effusion, pleural effusion or B ultrasound showedpericardial effusion (greater than 50ml or 3 mm) or pleural effusion (greater than 200ml or 10 mm);

  14. Liver or kidney dysfunction, chronic liver disease may have a potential impact onliver function, non-heart failure induced bilirubin or alkaline phosphatase > 2times the upper limit of normal, aspartate aminotransferase or alanineaminotransferase > 3 times the upper limit of normal, eGFR calculated using the MDRDmethod < 30 ml/min/1.73m2 ;

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

  16. Blood K + < 3.2 mmol/L or > 5.5 mmol/L;

  17. Subjects with an absolute change in LVEF > 5% as detected by CMR between screening 2and baseline;

  18. Women of childbearing age who are planning to become pregnant within 2 years (womenof childbearing age are defined as all women with physiological capability to becomepregnant), and pregnant or lactating women;

  19. Patients whose survival time is expected to be less than 6 months as judged by theinvestigator;

  20. Those who have participated in any drug clinical trial within the previous 3 months;

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

  22. The subjects with tumor history or is suffering from tumor now, or with precancerouslesions confirmed by pathological examination (such as breast ductal carcinoma insitu, or cervical dysplasia), or with malignant mass found by examination (physicalexamination, X-ray examination or B ultrasound examination or other means);

  23. The subjects with proliferative glands or adenomas that are found to have endocrineactivity that affects cardiac function or endocrine function detected byexaminations (physical examination, X-ray examination, B ultrasound examination orother means), such as pheochromocytoma, thyromegaly, etc. (patients with euthyroidthyroid or normal thyroid function do not need to be excluded);

  24. The subject, in the judgment of the Investigator, is unable to complete the study orto comply with the requirements of the study (for administrative or other reasons).

Study Design

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: Recombinant human Neuregulin for injection
Phase: 3
Study Start date:
December 10, 2020
Estimated Completion Date:
April 07, 2024

Study Description

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.

Connect with a study center

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing
    China

    Site Not Available

  • Beijing Chaoyang Hospital of Capital Medical University

    Beijing,
    China

    Site Not Available

  • Beijing Friendship Hospital of Capital Medical University

    Beijing,
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing,
    China

    Site Not Available

  • Fuwai hospital chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

  • China-Japan Union Hospital of Jilin University

    Changchun,
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun,
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha,
    China

    Site Not Available

  • Chongqing University Three Gorges Hospital

    Chongqing,
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian,
    China

    Site Not Available

  • First Affiliated Hospital,Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Site Not Available

  • Haikou People's Hospital

    Haikou,
    China

    Site Not Available

  • Hainan General Hospital

    Hainan,
    China

    Site Not Available

  • Hunan Provincial People's Hospital

    Hunan,
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan,
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan,
    China

    Site Not Available

  • Shandong Province QianFoshan Hospital

    Jinan,
    China

    Site Not Available

  • Luoyang Center Hospital

    Luoyang,
    China

    Site Not Available

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing,
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai JiaoTong University Ruijing Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai Putuo District Central Hospital

    Shanghai,
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang,
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou,
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan,
    China

    Site Not Available

  • Shanxi Cardiovascular Hospital

    Taiyuan,
    China

    Site Not Available

  • People's Hospital of Tianjin

    Tianjin,
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin,
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou,
    China

    Site Not Available

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