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

NCT04468529 | Completed Phase 3

• 1 other identifier: ZS-01-308
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 29

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.

Conditions

Chronic Systolic Heart Failure

Outcome Measures

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

  Day 30

Secondary Outcomes (7)

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

  Day 30 and Day 90

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

  Day 90

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

  Day 30 and Day 90

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

  Day 30 and Day 90

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

  Day 30 and Day 90

Study Arms (2)

Investigational drug group

EXPERIMENTAL

Injectable Neucardin + standard basic therapeutic medication

Drug: Recombinant human Neuregulin for injection

Placebo group

PLACEBO COMPARATOR

placebo + standard basic therapeutic medication

Drug: Placebo

Interventions

Recombinant human Neuregulin for injection DRUG

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

Also known as: Neucardin

Investigational drug group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, male or female;
• 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);
• Male NT-proBNP ≤1700 pg/ml or female NT-proBNP≤4000 pg/ml (detected by Roche kit in the central laboratory at screening 1);
• 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;
• Understand and sign the informed consent form.

You may not qualify if:

• Atrial fibrillation during the screening period;
• Conditions limiting CMR examination, such as installation of pacemakers, ICDs, CRTs or other similar devices contraindicated for CMR, or have claustrophobia;
• 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);
• Right heart failure due to lung disease;
• 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);
• Angina pectoris within 3 months;
• Myocardial infarction within the past 6 months;
• Cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months;
• Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months;
• History of heart transplantation, use of ventricular assist device (VAD) or preparation for heart transplantation, VAD;
• Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months;
• Serious arrhythmia (sustained ventricular tachycardia or other conditions meet the criteria according to the investigator's judgement );
• 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);
• 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 ;
• Systolic blood pressure \< 90 mmHg or \> 160 mmHg;

Sponsors & Collaborators

• Zensun Sci. & Tech. Co., Ltd.: lead

Study Sites (29)

Beijing Chaoyang Hospital of Capital Medical University

Beijing, China

Location

Beijing Friendship Hospital of Capital Medical University

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Fuwai hospital chinese Academy of Medical Sciences

Beijing, China

Location

China-Japan Union Hospital of Jilin University

Changchun, China

Location

The First Hospital of Jilin University

Changchun, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Chongqing University Three Gorges Hospital

Chongqing, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, China

Location

First Affiliated Hospital,Sun Yat-sen University

Guangzhou, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

Haikou People's Hospital

Haikou, China

Location

Hainan General Hospital

Hainan, China

Location

Hunan Provincial People's Hospital

Hunan, China

Location

Jinan Central Hospital

Jinan, China

Location

Qilu Hospital of Shandong University

Jinan, China

Location

Shandong Province QianFoshan Hospital

Jinan, China

Location

Luoyang Center Hospital

Luoyang, China

Location

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, China

Location

Shanghai First People's Hospital

Shanghai, China

Location

Shanghai JiaoTong University Ruijing Hospital

Shanghai, China

Location

Shanghai Putuo District Central Hospital

Shanghai, China

Location

Shengjing Hospital of China Medical University

Shenyang, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

First Hospital of Shanxi Medical University

Taiyuan, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, China

Location

People's Hospital of Tianjin

Tianjin, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Xinchun Yang, M.D

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is planned to conduct the study in several domestic clinical research sites at the same time. A total of 140 subjects will be enrolled, including 70 subjects in the investigational drug group and 70 subjects in the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, randomized, double-blind, standard therapy based, placebo-controlled parallel study.

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 13, 2020
• Study Start: December 10, 2020
• Primary Completion: April 12, 2022
• Study Completion: April 7, 2024
• Last Updated: July 25, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (29)