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.
This trial is planned to be conducted simultaneously in multiple clinical study sites nationwide, including 198 subjects, 99 subjects in the treatment group and 99 subjects in the placebo group. Primary endpoint: 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.) Secondary endpoints: 1. Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2 ; 2. Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2 ; 3. Change from baseline in LVEF, LVESV, LVEDV, LVESVI and LVEDVI at 35 days ; 4. 90-day response rate of LVESVI improved greater than or equal to 25ml/m2,LVEDVI improved greater than or equal to 25 ml/m2, and LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time ; 5. Change from baseline in LVEF, LVESV, LVEDV, LVESVI and LVEDVI at 90 days ; 6. Change from baseline in NYHA at 35 and 90 days ; 7. Change from baseline in quality of life at 35 and 90 days ; 8. Mortality during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
202
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)
Time frame: Day 35
Response rate at 35 day of left ventricular end systolic volume index (LVESVI) improvement greater than or equal to 25 ml/m2;
Response rate at 35 day of LVESVI improvement greater than or equal to 25 ml/m2;
Time frame: Day 35
Response rate at 35 day of left ventricular end diastolic volume index (LVEDVI) improvement greater than or equal to 25 ml/m2;
Response rate at 35 day of LVEDVI improvement greater than or equal to 25 ml/m2;
Time frame: Day 35
Change from baseline in left ventricular ejection fraction (LVEF) at 35 days;
Change from baseline in LVEF at 35 days;
Time frame: Day 35
Change from baseline in left ventricular end systolic volume (LVESV) at 35 days;
Change from baseline in LVESV at 35 days;
Time frame: Day 35
Change from baseline in left ventricular end diastolic volume (LVEDV) at 35 days;
Change from baseline in LVEDV at 35 days;
Time frame: Day 35
Change from baseline in LVESVI and LVEDVI at 35 days;
Change from baseline in LVESVI and LVEDVI at 35 days;
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Beijing Chao-Yang Hospital , Capital Medical University
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital , Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital , Capital Medical University
Beijing, Beijing Municipality, China
Chinese people's liberation army general hospital No.6 medical center
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Medical Center of General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Fuwai Hospital Chinese Academy of Medical Sciences
Beijin, Beijing Municipality, China
Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital)
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
...and 93 more locations
Time frame: Day 35
90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;
90-day response rate of LVESVI improved greater than or equal to 25 ml/m2;
Time frame: Day 90
90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;
90-day response rate of LVEDVI improved greater than or equal to 25 ml/m2;
Time frame: Day 90
90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;
90-day response rate of LVESVI and LVEDVI improved greater than or equal to 20 ml/m2 at the same time;
Time frame: Day 90
Change from baseline in LVEF at 90 days;
Change from baseline in LVEF at 90 days;
Time frame: Day 90
Change from baseline in LVESV at 90 days;
Change from baseline in LVESV at 90 days;
Time frame: Day 90
Change from baseline in LVEDV at 90 days;
Change from baseline in LVEDV at 90 days;
Time frame: Day 90
Change from baseline in LVESVI and LVEDVI at 90 days;
Change from baseline in LVESVI and LVEDVI at 90 days;
Time frame: Day 90
Change from baseline in New York Heart Association (NYHA) at 35 and 90 days;
Change from baseline in NYHA at 35 and 90 days;
Time frame: Day 35 and Day 90
Change from baseline in quality of life at 35 and 90 days;
Change from baseline in quality of life at 35 and 90 days;The benefit of patients is reflected by the quality of life score table.
Time frame: Day 35 and Day 90
Mortality during the study period;
Mortality during the study period;
Time frame: Through study completion, an estimation of average of 1 year