Chronic Systolic Heart Failure Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Based on Standard Treatment to Evaluate the Effect of Injectable Neucardin on Cardiac Function and Reverse Ventricular Remodeling in Patients With Chronic Systolic Heart Failure
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. ;
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