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

NCT05949801 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

  • Chronic Systolic Heart Failure

Interventions

DRUG

Neucardin

10 days IV infusion of 0.6 ug/kg/day

DRUG

Placebo

10 days IV infusion of 0 ug/kg/day

Sponsors & Collaborators

  • Zensun Sci. & Tech. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jian Zhang, M.D · Chinese Academy of Medical Sciences, Fuwai Hospital

  • Mulei Chen, M.D · Beijing Chao Yang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2024-08-30
Completion
2024-10-14

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05949801 on ClinicalTrials.gov