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CompletedNCT04468529Updated Jul 25, 2024

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

A Phase 3 interventional study of Recombinant human Neuregulin for injection and Placebo in Chronic Systolic Heart Failure, sponsored by Zensun Sci. & Tech. Co., Ltd.. Completed at 29 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Zensun Sci. & Tech. Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Chronic Systolic Heart Failure
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 154 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Zensun Sci. & Tech. Co., Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-75 years, male or female;
  2. Confirmed diagnosis of heart failure, in stable condition currently, NYHA class II-III, left ventricular ejection fraction (LVEF)≤40% (measured by echocardiography with modified Simpson's method at Screening 1, and measured by CMR at Screening 2 and baseline);
  3. Male NT-proBNP ≤1700 pg/ml or female NT-proBNP≤4000 pg/ml (detected by Roche kit in the central laboratory at screening 1);
  4. Receiving standard basic therapeutic medication for heart failure for more than 3 months, at the target dose or maximum tolerated dose for more than 1 month, or no change in dose within the last 1 month;
  5. Understand and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Atrial fibrillation during the screening period;
  2. Conditions limiting CMR examination, such as installation of pacemakers, ICDs, CRTs or other similar devices contraindicated for CMR, or have claustrophobia;
  3. Hypertrophic cardiomyopathy with outflow tract obstruction, constrictive pericarditis, significant and uncorrected valvular heart disease (severe regurgitation or severe stenosis or valvular disease requiring surgery), congenital heart disease requiring surgery but not yet undergoing surgical treatment, primary pulmonary 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 disturbance or acute decompensation within recent 1 month (symptoms and signs indicate chronic heart 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) or preparation for heart transplantation, VAD;
  11. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months;
  12. Serious arrhythmia (sustained ventricular tachycardia or other conditions meet the criteria according to the investigator's judgement );
  13. Clinical diagnosis of pericardial effusion, pleural effusion or B ultrasound showed pericardial 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 on liver function, non-heart failure induced bilirubin or alkaline phosphatase > 2 times the upper limit of normal, aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of normal, eGFR calculated using the MDRD method \< 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 2 and baseline;
  18. Women of childbearing age who are planning to become pregnant within 2 years (women of childbearing age are defined as all women with physiological capability to become pregnant), and pregnant or lactating women;
  19. Patients whose survival time is expected to be less than 6 months as judged by the investigator;
  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 precancerous lesions confirmed by pathological examination (such as breast ductal carcinoma in situ, or cervical dysplasia), or with malignant mass found by examination (physical examination, X-ray examination or B ultrasound examination or other means);
  23. The subjects with proliferative glands or adenomas that are found to have endocrine activity that affects cardiac function or endocrine function detected by examinations (physical examination, X-ray examination, B ultrasound examination or other means), such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid 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 or to comply with the requirements of the study (for administrative or other reasons).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Investigational drug group

    Injectable Neucardin + standard basic therapeutic medication

    Drug: Recombinant human Neuregulin for injection

  • Placebo comparator
    Placebo group

    placebo + standard basic therapeutic medication

    Drug: Placebo

Interventions

  • DrugRecombinant human Neuregulin for injection

    10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)

    Also known as: Neucardin

  • DrugPlacebo

    10 hours per day i.v. drip for the first 10 days (0ug/kg/day)

06

What researchers measure

Primary outcomes

  1. Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 30

    Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline

    Time frame: Day 30

Secondary outcomes

  1. Left Ventricular Ejection Fraction(LVEF) Change from baseline on day 30 and day 90

    Left Ventricular Ejection Fraction(LVEF) Change from baseline

    Time frame: Day 30 and Day 90

  2. Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 90

    Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline

    Time frame: Day 90

  3. Left Ventricular End-Systolic Volume(LVESV)change from baseline on day 30 and day 90

    Left Ventricular End-Systolic Volume(LVESV)change from baseline

    Time frame: Day 30 and Day 90

  4. Left Ventricular End-Diastolic Volume(LVEDV)change from baseline on day 30 and day 90

    Left Ventricular End-Diastolic Volume(LVEDV)change from baseline

    Time frame: Day 30 and Day 90

  5. Left Ventricular End-Diastolic Volume Index(LVEDVI )change from baseline on day 30 and day 90

    Left Ventricular End-Diastolic Volume Index(LVEDVI )

    Time frame: Day 30 and Day 90

  6. N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline on day 30 and day 90

    N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline

    Time frame: Day 30 and Day 90

  7. New York Heart Association(NYHA) class change from baseline on day 30 and day 90

    New York Heart Association(NYHA) class change from baseline

    Time frame: Day 30 and day 90

07

Study locations

29 sites
  • Beijing Chaoyang Hospital of Capital Medical University
    Beijing, China
  • Beijing Friendship Hospital of Capital Medical University
    Beijing, China
  • Chinese PLA General Hospital
    Beijing, China
  • Fuwai hospital chinese Academy of Medical Sciences
    Beijing, China
  • China-Japan Union Hospital of Jilin University
    Changchun, China
  • The First Hospital of Jilin University
    Changchun, China
  • The Second Xiangya Hospital of Central South University
    Changsha, China
  • Chongqing University Three Gorges Hospital
    Chongqing, China
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, China
  • First Affiliated Hospital,Sun Yat-sen University
    Guangzhou, China
  • Guangdong Provincial People's Hospital
    Guangzhou, China
  • Haikou People's Hospital
    Haikou, China
  • Hainan General Hospital
    Hainan, China
  • Hunan Provincial People's Hospital
    Hunan, China
  • Jinan Central Hospital
    Jinan, China
  • Qilu Hospital of Shandong University
    Jinan, China
  • Shandong Province QianFoshan Hospital
    Jinan, China
  • Luoyang Center Hospital
    Luoyang, China
  • Affiliated Drum Tower Hospital, Medical School of Nanjing University
    Nanjing, China
  • Shanghai First People's Hospital
    Shanghai, China
  • Shanghai JiaoTong University Ruijing Hospital
    Shanghai, China
  • Shanghai Putuo District Central Hospital
    Shanghai, China
  • Shengjing Hospital of China Medical University
    Shenyang, China
  • The First Affiliated Hospital of Soochow University
    Suzhou, China
  • First Hospital of Shanxi Medical University
    Taiyuan, China
  • Shanxi Cardiovascular Hospital
    Taiyuan, China
  • People's Hospital of Tianjin
    Tianjin, China
  • The Second Hospital of Tianjin Medical University
    Tianjin, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, China
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04468529
Lead sponsor
Zensun Sci. & Tech. Co., Ltd.
Responsible party
Sponsor
First posted
Jul 13, 2020
Start date
Dec 10, 2020
Primary completion
Apr 12, 2022
Completion
Apr 7, 2024
Last update
Jul 25, 2024

Study contacts

Xinchun Yang, M.D
principal investigator · Beijing Chao Yang Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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