A Phase 3 interventional study of Neucardin and Placebo in Chronic Systolic Heart Failure, sponsored by Zensun Sci. & Tech. Co., Ltd.. Completed at 103 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Zensun Sci. & Tech. Co., Ltd. · Phase 3, Interventional, and Treatment
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Among 11 studies in Heart Failure, Systolic with a site in China — 3 open to participants now, 4 under way, none of them phase 3. Heart Failure, Systolic · China.
Among the 11 studies in Heart Failure, Systolic with a site in China, this one is one of 2 that started in 2023, is one of 4 in phase 3, and was the 8th registered.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
Browse Heart Failure, Systolic studies →3 of the 11 studies in Heart Failure, Systolic with a site in China are open now. Recruiting first, the newest first:
Ruijin Hospital Luwan Branch · Sites in China
Ages 18–90
Sunnybrook Health Sciences Centre · Sites in China, United States, Austria and 13 more countries
Ages 18+
The University of Hong Kong-Shenzhen Hospital · Sites in China
Ages 18+ · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 29 Heart Failure, Systolic studies recruiting now, 19 (66%) set no upper age limit and 2 (7%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 5
First in 2004; this study’s year is marked. 2 started in 2023.
This study's enrollment of 202 is above the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Median enrollment 178 across the 8 interventional studies, 1,618 across the 3 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 11 have an industry lead sponsor. The 9 most frequent:
Zensun Sci. & Tech. Co., Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Zensun Sci. & Tech. Co., Ltd. has 3 studies filed under Heart Failure, Systolic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Heart Failure, Systolic with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neucardin+standard basic therapeutic medication
Drug: Neucardin
Placebo + standard basic therapeutic medication
Drug: Placebo
10 days IV infusion of 0.6 ug/kg/day
Also known as: Recombinant human Neuregulin-1 for Injection
10 days IV infusion of 0 ug/kg/day
Also known as: Excipients of recombinant human neuregulin-1 freeze dried for injection
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;
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
Showing the first 100 of 103 sites. Choose a country and city above to see the rest.
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.
Ran from Apr 2023 to primary completion in Aug 2024, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human NEUREGULIN-1 recombinant (177-237)
Zensun Sci. & Tech. Co., Ltd.