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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
154
10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)
10 hours per day i.v. drip for the first 10 days (0ug/kg/day)
Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 30
Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline
Time frame: Day 30
Left Ventricular Ejection Fraction(LVEF) Change from baseline on day 30 and day 90
Left Ventricular Ejection Fraction(LVEF) Change from baseline
Time frame: Day 30 and Day 90
Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline on day 90
Left Ventricular End-Systolic Volume Index(LVESVI) change from baseline
Time frame: Day 90
Left Ventricular End-Systolic Volume(LVESV)change from baseline on day 30 and day 90
Left Ventricular End-Systolic Volume(LVESV)change from baseline
Time frame: Day 30 and Day 90
Left Ventricular End-Diastolic Volume(LVEDV)change from baseline on day 30 and day 90
Left Ventricular End-Diastolic Volume(LVEDV)change from baseline
Time frame: Day 30 and Day 90
Left Ventricular End-Diastolic Volume Index(LVEDVI )change from baseline on day 30 and day 90
Left Ventricular End-Diastolic Volume Index(LVEDVI )
Time frame: Day 30 and Day 90
N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline on day 30 and day 90
N-Terminal pro-Brain Natriuretic Peptide(NT-proBNP) change from baseline
Time frame: Day 30 and Day 90
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Beijing Chaoyang Hospital of Capital Medical University
Beijing, China
Beijing Friendship Hospital of Capital Medical University
Beijing, China
Chinese PLA General Hospital
Beijing, China
Fuwai hospital chinese Academy of Medical Sciences
Beijing, China
China-Japan Union Hospital of Jilin University
Changchun, China
The First Hospital of Jilin University
Changchun, China
The Second Xiangya Hospital of Central South University
Changsha, China
Chongqing University Three Gorges Hospital
Chongqing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
...and 19 more locations
New York Heart Association(NYHA) class change from baseline on day 30 and day 90
New York Heart Association(NYHA) class change from baseline
Time frame: Day 30 and day 90