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

Chronic Systolic Heart Failure Clinical Trial

Official title:
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure on Standard Heart Failure Therapy

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04468529
Study type	Interventional
Source	Zensun Sci. & Tech. Co., Ltd.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	December 10, 2020
Completion date	May 20, 2022

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See also
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