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Chronic Systolic Heart FailurePhase 3NCT05949801

Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure

A Phase 3 study testing Neucardin in people with Chronic Systolic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 103 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Systolic Heart Failure
What is being tested?
Neucardin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
202 participants
Where
103 sitesChina
Study dates
13 Apr 2023to 14 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years, male or female;
  • Definite diagnosis of heart failure for 6 months or more, current stable disease, NYHA class II-III, left ventricular ejection fraction (LVEF) ≤ 40%(echocardiographic modified Simpson's method measurement ≤ 40% at screening, and CMR measurement ≤ 40% at baseline);
  • NT-proBNP ≤1700 pg/ml in males and ≤4000pg/ml in females (detected by Roche kit in central laboratory);
  • Receiving standard basic treatment for heart failure for at least 3 months, and did not change the type and dose of heart failure treatment drugs within 1 month;
  • Understand and sign the informed consent form.

Who cannot join

  • Unable to receive CMR examination, such as patients with pacemakers, ICDs, CRTs, or other similar devices contraindicated for CMR, claustrophobia, atrial fibrillation during the screening period, or inability to cooperate with air-closed activities required for CMR testing;
  • Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, constrictive pericarditis, significant and uncorrected valvular heart disease, severe valvular regurgitation or severe stenosis, congenital heart disease requiring surgical treatment but not surgical treatment, primary pulmonary hypertension or secondary severe pulmonary hypertension (≥ 70 mmHg), and right heart failure due to pulmonary disease;
  • Patients suffering from proliferative glands or adenomas with endocrine activity which may affect cardiac function or endocrine function, such as pheochromocytoma, thyromegaly, etc. (patients with euthyroid thyroid nodules do not need to be excluded);
  • LVESVi less than 135 ml/m2 at baseline;
  • Prepare to install pacemaker, ICD, CRT or other similar devices within 6 months;
  • History of heart transplantation, use of ventricular assist devices (VADs) or preparation for heart transplantation, VADs;
Show all 21Show fewer
  • Diagnosis of peripartum or chemotherapy-induced cardiomyopathy within the past 12 months;
  • Subjects with chronic heart failure with acute hemodynamic disturbance or acute decompensation within the past 1 month (symptoms and signs prove that chronic heart failure is aggravated and intravenous drug therapy is required);
  • Angina pectoris within the past 3 months;
  • Myocardial infarction, cerebrovascular accident, revascularization (PCI or other surgery), cardiac surgery, carotid artery or other large vessel surgery within the past 6 months;
  • Serious ventricular arrhythmias (sustained ventricular tachycardia or other conditions that the investigator considers necessary to exclude);
  • Clinical diagnosis of pericardial effusion, pleural effusion or imaging showed pericardial effusion (greater than 50ml or 3 mm or a small amount or more) or pleural effusion (greater than 200ml or 10 mm);
  • Liver and kidney dysfunction and chronic liver disease may have a potential impact on liver function (such as active chronic hepatitis, etc.), non-heart failure causes of bilirubin or alkaline phosphatase > 2 times the upper limit of normal, aspartate aminotransferase and/or alanine aminotransferase > 3 times the upper limit of normal, eGFR calculated using MDRD method < 30 ml/min/1.73 m2;
  • Systolic blood pressure < 90 mmHg or > 160 mmHg;
  • Serum K + < 3.2 mmol/L or > 5.5 mmol/L;
  • Women of childbearing potential who plan to become pregnant within 2 years (women of childbearing potential are defined as all women with physical ability to become pregnant), pregnant or lactating women;
  • Previous history of cancer or current cancer, or pathological examination confirmed precancerous lesions (Such as ductal carcinoma in situ of the breast, or atypical hyperplasia of the cervix), or through the examination (physical examination, X-ray examination or B ultrasound examination or other means) found in vivo malignant mass subjects;
  • The investigator judges that the survival time is expected to be less than 6 months;
  • Participated in any drug clinical trials within the first 3 months;
  • Severe neurological disease (Alzheimer's disease, progressive parkinsonism);
  • Subjects who are unable to complete this study or fail to comply with the requirements of this study (due to administrative reasons or other reasons), as judged by the investigator.

Trial locations and contacts

103 sites in 1 country.

103 sites in 1 country

China103 sites

  • Ansteel Group Genral Hospital

    Anshan, Liaoning

  • Anyang People's Hospital (Anyang Central Hospital)

    Anyang, Henan

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijin, Beijing Municipality, 100037

  • Beijing Chao-Yang Hospital , Capital Medical University

    Beijing, Beijing Municipality, 100037

  • Beijing Anzhen Hospital , Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital , Capital Medical University

    Beijing, Beijing Municipality

  • Chinese people's liberation army general hospital No.6 medical center

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • The First Medical Center of General Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality

  • Benxi Central Hospital

    Benxi, Liaoning

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • Jilin University Second Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • People's Hospital of Hunan Provincial

    Changsha, Hunan

  • Changzhou No.2 People's Hospital

    Changzhou, Jiansu

  • The First People's Hospital of Changzhou

    Changzhou, Jiansu

  • The Fifth People's Hospital of Chengdu

    Chengdu, Sichuan

  • Chenzhou First People's Hospital

    Chenzhou, Huanan

  • Chongqing Emergency Medical Center (Chongqing Fourth People's Hospital)

    Chongqing, Chongqing Municipality

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Dali University

    Dali, Yunnan

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

  • Zhongshan Hospital Affiliated to Dalian University

    Dalian, Liaoning

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang

  • First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

  • Haikou People's Hospital

    Haikou, Hainan

  • Hainan Provincial People's Hospital

    Haikou, Hainan

  • The First Affiliated Hospital , Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Affiliated Hospital of Hangzhou Normal University

    Hanzhou, Zhejiang

  • Sir Run Run Shaw Hospital

    Hanzhou, Zhejiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Nanyang Second People's Hospital

    Henan, Nanyang

  • South China University Affiliated South China Hospital

    Hengyang, Hunan

  • The Second Affiliated Hospital of Nanhua University

    Hengyang, Hunan

  • Heze Municipal Hospital

    Heze, Shandong

  • Huai'an First People's Hospital

    Huai'an, Jiansu

  • Jiaxing First Hospital

    Jiaxing, Zhejiang

  • Guangdong Jieyang People's Hospital

    Jieyang, Guangdong

  • Jinan Central Hospital

    Jinan, Shandong

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Province Qianfoshan Hospital

    Jinan, Shandong

  • Affiliated Hospital of Jining Medical College

    Jining, Shangdong

  • Jining first people's hospital

    Jining, Shangdong

  • Huaihe Hospital of Henan University

    Kaifeng, Henan

  • Fuwai Yunnan Cardiovascular Hospital

    Kunming, Yunnan

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • Linyi People's Hospital

    Linyi, Shandong

  • Liuzhou worker's hospital

    Liuzhou, Guangxi

  • Longyan First Hospital

    Longyan, Fujian

  • First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Luoyang Central Hospital

    Luoyang, Henan

  • Maoming people's hospital

    Maoming, Guangdong

  • Mianyang Central Hospital

    Mianyang, Sichuan

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiansu

  • Zhongda Hospital Southeast University

    Nanjing, Jiansu

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Nanyang Central Hospital

    Nanyang, Henan

  • Nanyang First People's Hospital

    Nanyang, Henan

  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences (Ningbo Second Hospital)

    Ningbo, Zhejiang

  • The First Hospital of Ningbo

    Ningbo, Zhejiang

  • General Hospital of Puyang Oilfield

    Puyang, Henan

  • Qiqihar first hospital

    Qiqihar, Heilongjiang

  • Sanmenxia Central Hospital

    Sanmenxia, Henan

  • Putuo District Central Hospital of Shanghai

    Shanghai, Shanghai Municipality

  • Shanghai Baoshan District Wusong Central Hospital

    Shanghai, Shanghai Municipality

  • First People's Hospital of Shangqiu

    Shangqiu, Henan

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiansu

  • The Suzhou Municipal Hospital

    Suzhou, Jiansu

  • Tai'an City Central Hospital

    Tai’an, Shandong

  • Shanxi Provincial Cardiovascular Hospital

    Taiyuan, Shanxi

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • First affiliated hospital of Wenzhou medical university

    Wenzhou, Zhejiang

  • People's Hospital of Wuhan University

    Wuhan, Hubei

  • Wuhan Wuchang Hospital

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi

  • Xi'an Gaoxin Hospital

    Xi’an, Shanxi

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen, Fujian

  • Xiangyang Central Hospital

    Xiangyang, Hubei

  • Xiangyang first people's hospital

    Xiangyang, Hubei

  • Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

    Xianyang, Shanxi

  • Xianyang first people's hospital

    Xianyang, Shanxi

  • Xianyang Hospital of Yan 'an University

    Xianyang, Shanxi

  • The First Affiliated Hospital of Xinxiang Medical College

    Xinxiang, Henan

  • Xinxiang central hospital

    Xinxiang, Henan

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiansu

  • Xuzhou Central Hospital

    Xuzhou, Jiansu

  • Subei people's hospital

    Yangzhou, Jiansu

  • Yueyang Central Hospital

    Yueyang, Hunan

  • Zaozhuang municipal hospital

    Zaozhuang, Shangdong

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • The First Affiliated Hospital of Henan University

    Zhengzhou, Henan

  • Zhumadian Central Hospital

    Zhumadian, Henan

  • Zibo Municipal Hospital

    Zibo, Shandong

Other trials in China

About this study

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.

Read the detailed description

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.
Being tested
Neucardin, Placebo
Keywords
CHF Neucardin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeucardinDrug

    Also called Recombinant human Neuregulin-1 for Injection

    10 days IV infusion of 0.6 ug/kg/day

  • PlaceboDrug

    Also called Excipients of recombinant human neuregulin-1 freeze dried for injection

    10 days IV infusion of 0 ug/kg/day

Study groups in NCT05949801
Study groupRoleWhat they receive
Investigational drug groupExperimentalNeucardin+standard basic therapeutic medication
Receives: Drug: Neucardin
placebo groupPlacebo comparatorPlacebo + standard basic therapeutic medication
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    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)

    Measured: Day 35

Secondary outcomes (16)

  1. 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;

    Measured: Day 35

  2. 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;

    Measured: Day 35

  3. Change from baseline in left ventricular ejection fraction (LVEF) at 35 days;

    Change from baseline in LVEF at 35 days;

    Measured: Day 35

  4. Change from baseline in left ventricular end systolic volume (LVESV) at 35 days;

    Change from baseline in LVESV at 35 days;

    Measured: Day 35

  5. Change from baseline in left ventricular end diastolic volume (LVEDV) at 35 days;

    Change from baseline in LVEDV at 35 days;

    Measured: Day 35

  6. Change from baseline in LVESVI and LVEDVI at 35 days;

    Change from baseline in LVESVI and LVEDVI at 35 days;

    Measured: Day 35

  7. 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;

    Measured: Day 90

  8. 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;

    Measured: Day 90

  9. 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;

    Measured: Day 90

  10. Change from baseline in LVEF at 90 days;

    Change from baseline in LVEF at 90 days;

    Measured: Day 90

  11. Change from baseline in LVESV at 90 days;

    Change from baseline in LVESV at 90 days;

    Measured: Day 90

  12. Change from baseline in LVEDV at 90 days;

    Change from baseline in LVEDV at 90 days;

    Measured: Day 90

  13. Change from baseline in LVESVI and LVEDVI at 90 days;

    Change from baseline in LVESVI and LVEDVI at 90 days;

    Measured: Day 90

  14. Change from baseline in New York Heart Association (NYHA) at 35 and 90 days;

    Change from baseline in NYHA at 35 and 90 days;

    Measured: Day 35 and Day 90

  15. 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.

    Measured: Day 35 and Day 90

  16. Mortality during the study period;

    Mortality during the study period;

    Measured: Through study completion, an estimation of average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start13 Apr 2023
  3. Primary completion30 Aug 2024
  4. Study completion14 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05949801
Sponsor's protocol ID
ZS-01-308B
Status last verified
Jan 2025
First submitted
2 Jun 2023
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Neucardin in people with Chronic Systolic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 103 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05949801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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