A Phase 3 interventional study of Recombinant human Neuregulin for injection and Placebo in Chronic Systolic Heart Failure, sponsored by Zensun Sci. & Tech. Co., Ltd.. Completed at 29 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Zensun Sci. & Tech. Co., Ltd. · Phase 3, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 154 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Zensun Sci. & Tech. Co., Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Injectable Neucardin + standard basic therapeutic medication
Drug: Recombinant human Neuregulin for injection
placebo + standard basic therapeutic medication
Drug: Placebo
10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)
Also known as: Neucardin
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
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
Plan to share: No — Zensun ensures that the key information about the design of this protocol will be published in a publicly available database such as www.clinicaltrials.gov. After the end of the trial, Zensun will assist the study site to objectively summarize the trial results, use appropriate statistical methods to analyze the trial data, objectively evaluate the safety and efficacy of the drug according to the results, and make a complete written summary report of the clinical trial. Study results will be submitted for publication and/or publication in a publicly available database. If other individuals or institutions related to this study want to publish or publish the study results or related data, they need to obtain the consent of the sponsor in advance. If the sponsor needs to include the name of the investigators in any publication or advertisement, the consent of the investigator should be obtained.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Zensun Sci. & Tech. Co., Ltd.