A Multi-center, Randomized, Double-blined, Placebo Parallel Controlled Phase III Clinical Trial to Evaluate the Effect of Injectable Neucardin on the Mortality of Subjects With Chronic Systolic Heart Failure on Standard HF Therapy.

NCT03388593 Phase 3 UNKNOWN

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III.

Details

Lead sponsor	Zensun Sci. & Tech. Co., Ltd.
Phase	Phase 3
Status	UNKNOWN
Enrolment	1600
Start date	2018-07-23
Completion	2026-02

Conditions

• Chronic Heart Failure

Interventions

• rhNRG-1
• Placebo

Primary outcomes

• All-cause mortality — 1 year
  Including deaths from cardiovascular and non-cardiovascular causes, Log-Rank test was used for comparison between groups, and Kaplan-Meier survival curves were plotted; COX proportional hazard model was used to estimate the HR and its 95% confidence interval.

Countries

China