NCT05949801|CompletedPhase 3DMC

Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure

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

Zensun Sci. & Tech. Co., Ltd.ClinicalTrials.gov

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1 other identifier

ZS-01-308B

Study Type

interventional

Target

202

Locations

1 country

Sites

103

Timeline

RegisteredJul 2023

StartedApr 2023

CompletionOct 2024

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

202

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2023

Geographic Reach

1 country

103 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

April 13, 2023

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2023

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

June 2, 2023

Last Update Submit

January 23, 2025

Conditions

Chronic Systolic Heart Failure

Keywords

CHF Neucardin

Outcome Measures

Primary Outcomes (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)
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

Secondary Outcomes (16)

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 left ventricular end diastolic volume index (LVEDVI) improvement greater than or equal to 25 ml/m2;
Day 35
Change from baseline in left ventricular ejection fraction (LVEF) at 35 days;
Day 35
Change from baseline in left ventricular end systolic volume (LVESV) at 35 days;
Day 35
Change from baseline in left ventricular end diastolic volume (LVEDV) at 35 days;
Day 35
+11 more secondary outcomes

Study Arms (2)

Investigational drug group

EXPERIMENTAL

Neucardin+standard basic therapeutic medication

Drug: Neucardin

placebo group

PLACEBO COMPARATOR

Placebo + standard basic therapeutic medication

Drug: Placebo

Interventions

NeucardinDRUG

10 days IV infusion of 0.6 ug/kg/day

Also known as: Recombinant human Neuregulin-1 for Injection

Investigational drug group

PlaceboDRUG

10 days IV infusion of 0 ug/kg/day

Also known as: Excipients of recombinant human neuregulin-1 freeze dried for injection

placebo group

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years, male or female;
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);
NT-proBNP ≤1700 pg/ml in males and ≤4000pg/ml in females (detected by Roche kit in central laboratory);
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;
Understand and sign the informed consent form.

You may not qualify if:

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;
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;
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);
LVESVi less than 135 ml/m2 at baseline;
Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months;
History of heart transplantation, use of ventricular assist devices (VADs) or preparation for heart transplantation, VADs;
Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months;
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);
Angina pectoris within the past 3 months;
Myocardial infarction, cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months;
Serious ventricular arrhythmias (sustained ventricular tachycardia or other conditions that the investigator considers necessary to exclude);
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);
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;
Systolic blood pressure \< 90 mmHg or \> 160 mmHg;
Serum K + \< 3.2 mmol/L or \> 5.5 mmol/L;
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Zensun Sci. & Tech. Co., Ltd.lead

Study Sites (103)

Beijing Chao-Yang Hospital , Capital Medical University

Beijing, Beijing Municipality, 100037, China

Location

Beijing Anzhen Hospital , Capital Medical University