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

NCT ID: NCT04468529

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2024-04-07

Brief 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.

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.

Conditions

Chronic Systolic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investigational drug group

Injectable Neucardin + standard basic therapeutic medication

Group Type: EXPERIMENTAL

Recombinant human Neuregulin for injection

Intervention Type: DRUG

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

Placebo group

placebo + standard basic therapeutic medication

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Recombinant human Neuregulin for injection

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Neucardin

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zensun Sci. & Tech. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinchun Yang, M.D

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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

Countries

China

Other Identifiers

ZS-01-308

Identifier Type: -

Identifier Source: org_study_id