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Chronic Heart FailurePhase 3NCT03388593

Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure.

A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 65 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Heart Failure
What is being tested?
rhNRG-1
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,600 participants
Where
65 sitesChina
Study dates
23 Jul 2018to Feb 2026
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

  • 1. Age between 18 and 75, gender balance (no more than 960 subjects of either gender in total 1600 subjects).
  • 2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  • 3. Subjects with chronic heart failure (NYHA class II OR III ).
  • 4. 600 pg/ml ≤NT-proBNP≤1700 pg/ml ( by Roche assay Kit in central lab).
  • 5. Diagnosed as chronic systolic heart failure (history, symptoms, signs), and in stable condition in the last one month.
  • 6. Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for one month before randomization.
  • 7. Capable of signing the informed consent form.

Who cannot join

  • 1. New chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
  • 2. NYHA functional class I OR IV.
  • 3. NT-proBNP < 600 pg/ml OR NT-proBNP>1700 pg/ml (by Roche assay Kit in central lab).
  • 4. Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
  • 5. Ischemic heart failure without recanalization or with recanalization in recent six months.
  • 6. Acute MI in the last 3 months.
Show all 26Show fewer
  • 7. Unstable angina.
  • 8. Patients with acute pulmonary edema or acute hemodynamic disorder.
  • 9. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month (symptoms and signs suggest worsening chronic heart failure and may require intravenous drug therapy).
  • 10. Patients with right heart failure caused by pulmonary disease.
  • 11. Patients diagnosed with pericardial effusion (>50 ml) or pleural effusion(>200 ml), or evidenced by Echocardiogram.
  • 12. Cardiac surgery or cerebrovascular accident within recent six months.
  • 13. Preparing for heart transplantation or CRT, or has received CRT.
  • 14. Serious ventricular arrhythmia (sustained ventricular tachycardia or frequent paroxysmal ventricular tachycardia).
  • 15.Diagnosis of perinatal or chemotherapy-induced cardiomyopathy in last 12 months.
  • 16. Serious hepatic or renal dysfunction (bilirubin 1.5 times above the normal upper limit, AST or ALT 2 times above the normal upper limit, serum creatinine>2.0mg/dL, HBV or HCV positive).
  • 17. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  • 18. Systolic blood pressure <90mmHg or >160mmHg.
  • 19. Women of childbearing age who have a pregnancy plan within 2 years (women of childbearing age are defined as women who have a pregnancy physiology).
  • 20. Pregnant or lactating women.
  • 21. Patients who participated in any clinical trial in the recent three months.
  • 22. Subject with a life expectancy less than 6 months as assessed by the investigator.
  • 23. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
  • 24. History of any malignancy or suffering from cancer, or biopsy proven pre-malignant condition (e.g., DICS or cervical atypia).
  • 25. Evidence (physical examination, chest X-ray (CXR), ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm that has an effect on heart function or the endocrine system, e.g., pheochromocytoma or hyperthyroidism (Thyroid nodules with normal thyroid function do not need to be excluded).
  • 26. As judged by the investigator that the subject cannot complete the study or adhere to the study requirements (due to the management reasons or others).

Trial locations and contacts

65 sites in 1 country.

Xiaorui Wang, Ph.D contact

86-21-50802627 ext. 196

wangxiaorui@zensun.com

Runlin Gao, Ph.D,MD contact

65 sites in 1 country

China65 sites, 64 recruiting

  • The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology

    Baotou, Inner Mongolia

    Xuefeng Lin

    Xuefeng Lin

    Recruiting

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, Beijing Municipality, 100010

    Hongxu Liu

    Hongxu Liu

    Recruiting

  • Navy General Hospital

    Beijing, Beijing Municipality, 100048

    Tianchang Li

    Tianchang Li

    Recruiting

  • Beijing Jingmei Group General Hospital

    Beijing, Beijing Municipality

    Jianping Luo

    Jianping Luo

    Recruiting

  • Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Jian Zhang, MD, Ph.D, 86-10-88398772

    Jian Zhang, MD, Ph.D

    Recruiting

  • Affiliated Hospital of Changchun University of Chinese Medicine

    Changchun, Jilin, 130021

    Yue Deng

    Yue Deng

    Recruiting

  • Jilin Academy of Traditional Chinese Medicine

    Changchun, Jilin, 130021

    Shurong Liu

    Shurong Liu

    Recruiting

  • Jilin University Sino-Japanese Friendship Hospital

    Changchun, Jilin

    Fanbo Meng

    Fanbo Meng

    Recruiting

  • The First Affiliated Hospital of Jilin University

    Changchun, Jilin

    Yushi Wang

    Yushi Wang

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

    Zaixin Yu

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan

    Jianqiang Peng

    Jianqiang Peng

    Recruiting

  • Chifeng Municipal Hospital

    Chifeng, Inner Mongolia, 024000

    Xiandong Sun

    Xiandong Sun

    Recruiting

  • Affiliated Hospital of Chongqing Three Gorges Medical College

    Chongqing, Chongqing Municipality, 404000

    Gang Xiong

    Gang Xiong

    Recruiting

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing Municipality

    Ying Zhang

    Recruiting

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality

    Xiaohua Pang

    Xiaohua Pang

    Recruiting

  • Pepole's hospital of DeYang city

    Deyang, Sichuan, 618000

    Xiaojian Deng

    Xiaojian Deng

    Recruiting

  • Sun Yai-sen Memorial hospital Sun Yai-sen University

    Guangzhou, Guangdong, 510120

    Jingfeng Wang

    Jingfeng Wang

    Recruiting

  • Guangdong Second Provincial Central Hospital

    Guangzhou, Guangdong, 510317

    Yuhui Li

    Yuhui Li

    Recruiting

  • Guangzhou Panyu Central Hospital

    Guangzhou, Guangdong, 511400

    Guoqin Chen

    Guoqin Chen

    Recruiting

  • Haikou People's Hospital

    Haikou, Hainan

    Shijuan Lu

    Shijuan Lu

    Recruiting

  • HanDan Central Hospital

    Handan, Hebei, 056001

    Hongsen Tian

    Hongsen Tian

    Recruiting

  • First Hospital of Handan

    Handan, Hebei, 056002

    Xiufeng Zhao

    Xiufeng Zhao

    Recruiting

  • Shulan (Hangzhou) Hospital

    Hangzhou, Zhejiang, 310000

    Liping Ma

    Liping Ma

    Recruiting

  • The Second Hospital. University of South China

    Hengyang, Hunan, 421001

    Gaofeng Zeng

    Gaofeng Zeng

    Recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Wei Miao

    Wei Miao

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Ming Zhong, MD,Ph.D

    Ming Zhong, MD,Ph.D

    Recruiting

  • Jiujiang Hospital Affiliated to Nanchang University

    Jiujiang, Jiangxi, 332000

    Xihu Yin

    Xihu Yin

    Recruiting

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475000

    Ruili He

    Ruili He

    Recruiting

  • The Third People's Hospital of Yunnan Province

    Kunming, Yunnan, 650011

    Yunfei Hong

    Recruiting

  • The Second Hospital of Kunming Medical College

    Kunming, Yunnan

    Wenwei Bai

    Wenwei Bai

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang

    Jianjun Jiang

    Jianjun Jiang

    Recruiting

  • The First People's Hospital of Luoyang

    Luoyang, Henan

    Qunsheng Zhang

    Qunsheng Zhang

    Recruiting

  • Meihekou Central Hospital

    Meihekou, Jilin, 135000

    Jinliang Zhang

    Jinliang Zhang

    Recruiting

  • The Second People's Hospital of Neijiang

    Neijiang, Sichuan

    Quanwei Liu

    Quanwei Liu

    Recruiting

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001

    Fuxian Ren

    Fuxian Ren

    Recruiting

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang, 161002

    Haifeng Shao

    Haifeng Shao

    Recruiting

  • Quzhou people's hospital

    Quzhou, Zhejiang

    Xiaoming Tu

    Xiaoming Tu

    Recruiting

  • The Third People's Hospital of Hainan Province

    Sanya, Hainan

    Ling Lin

    Ling Lin

    Recruiting

  • Central hospital of minhang District

    Shanghai, Shanghai Municipality, 200000

    Wei Hu

    Wei Hu

    Recruiting

  • The Sixth People's Hospital, Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, shanghai

    Jingwei Pan

    Jingwei Pan

    Recruiting

  • Shanghai Oriental hospital

    Shanghai, Shanghai Municipality

    Huimin Fan

    Huimin Fan

    Recruiting

  • Shanghai Yangpu District Central Hospital

    Shanghai, Shanghai Municipality

    Jiahong Wang

    Jiahong Wang

    Recruiting

  • The Central Hospital of Putuo District, Shanghai

    Shanghai, Shanghai Municipality

    Zongjun Liu, MD,Ph.D

    Zongjun Liu, MD,Ph.D

    Recruiting

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning, 110016

    Zhanquan Li

    Zhanquan Li

    Recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning

    Shumei Ma

    Shumei Ma

    Recruiting

  • 980 Hospital of PLA Joint Logistics Support Force (Bethune International Peace Hospital)

    Shijiazhuang, Hebei, 05000

    Ru Leisheng

    Ru Leisheng

    Recruiting

  • Siping Central People's Hospital

    Siping, Jilin

    Zhihua Fang

    Zhihua Fang

    Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

    Zhiming Yang

    Zhiming Yang

    Recruiting

  • Shanxi cardiovascular disease hospital

    Taiyuan, Shanxi, 030024

    Huiyuan Han

    Huiyuan Han

    Recruiting

  • Taiyuan City Central Hospital

    Taiyuan, Shanxi

    Suspended

  • Wuqing pepole's hospital

    Tianjing, Tianjing, 300000

    Feng Ling

    Feng Ling

    Recruiting

  • Tonghua Central Hospital

    Tonghua, Jilin, 134000

    Xuxia Zhang

    Xuxia Zhang

    Recruiting

  • The Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi, 712000

    Ling Chen

    Ling Chen

    Recruiting

  • The Second Affiliated Hospital of Xingtai Medical College

    Xingtai, Hebei, 054000

    Dongmei Gao

    Dongmei Gao

    Recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei, 054000

    Qingmin Wei

    Qingmin Wei

    Recruiting

  • Fourth Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Xinjiang, 830054

    Peng Li

    Peng Li

    Recruiting

  • The First People's Hospital of Xinxiang

    Xinxiang, Henan

    Guiye Zhao

    Guiye Zhao

    Recruiting

  • Pepole's hospital of Xinzheng

    Xinzheng, Henan, 451150

    Yanhong Li

    Yanhong Li

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, Jiangsu

    Yong Xia

    Yong Xia, MD,Ph.D

    Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001

    Jianying Chen

    Jianying Chen

    Not yet recruiting

  • Zhengzhou First People's Hospital

    Zhengzhou, Henan, 450004

    Hongwei Yu

    Hongwei Yu

    Recruiting

  • Luoyang center hospital

    Zhengzhou, Henan, 471099

    Shouyan Zhang

    Shouyan Zhang

    Recruiting

  • Henan Provincial Chest Hospital

    Zhengzhou, Henan

    Juan Chen

    Juan Chen

    Recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong

    Xiufang Lin

    Recruiting

  • The First People's Hospital of Zunyi

    Zunyi, Guizhou, 133012

    Qianfeng Jiang

    Qianfeng Jiang

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, Randomized, Double-blined, Placebo Parallel Controlled Phase III Clinical Trial to Evaluate the Effect of Injectable Neucardin on the Mortality of Subjects With Chronic Systolic Heart Failure on Standard HF Therapy.

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III.

Read the detailed description

The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trials, phase II clinical trials and already completed phase III clinical trails have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. More importantly, rhNRG-1 can significantly reduce the mortality of heart failure subjects with baseline NT-proBNP level ≤1600 fmol/mL and NYHA class II to III. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III.

Being tested
rhNRG-1, Placebo
Keywords
chronic heart failure, neuregulin, mortality
Medical subject headings
Fibromatosis, Gingival, 2

What participants receive

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

  • rhNRG-1Drug

    Also called Neucardin™

    10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks

  • PlaceboDrug

    10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks

Study groups in NCT03388593
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo in addition to standard therapy
Receives: Drug: Placebo
rhNRG-1ExperimentalrhNRG-1 in addition to standard therapy
Receives: Drug: rhNRG-1

What is being measured

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

  1. All-cause mortality

    Including deaths from cardiovascular and non-cardiovascular causes, Log-Rank test was used for comparison between groups, and Kaplan-Meier survival curves were plotted; COX proportional hazard model was used to estimate the HR and its 95% confidence interval.

    Measured: 1 year

Secondary outcomes (7)

  1. Mortality caused by cardiovascular events

    Log-Rank test was used for comparison between groups, and Kaplan-Meier survival curves were plotted; COX proportional hazard model was used to estimate the HR and its 95% confidence interval.

    Measured: 1 year

  2. All-cause mortality of female subjects

    Log-Rank test was used for comparison between groups, and Kaplan-Meier survival curves were plotted; COX proportional hazard model was used to estimate the HR and its 95% confidence interval.

    Measured: 1 year

  3. All-cause mortality of male subjects

    Log-Rank test was used for comparison between groups, and Kaplan-Meier survival curves were plotted; COX proportional hazard model was used to estimate the HR and its 95% confidence interval.

    Measured: 1 year

  4. Percentage of all-cause re-hospitalization

    The Kaplan-Meier curve was used to describe the cumulative incidence rate of the first re-hospitalization, and the differences between the two groups were compared using Log-Rank.

    Measured: 1 year

  5. Percentage of Participants with re-hospitalization caused by worsening heart failure

    The Kaplan-Meier curve was used to describe the cumulative incidence rate of the first re-hospitalization, and the differences between the two groups were compared using Log-Rank.

    Measured: 1 year

  6. Change of NT-proBNP level at the 25th week and 52th week

    The paired t test or signed rank sum test was used to compare the changes before and after treatment in each group, and the comparison between groups was performed by analysis of variance or Wilcoxon rank sum test.

    Measured: 1 year

  7. New York Heart Association (NYHA) functional classification

    For the NYHA cardiac functional grading after administration, summarize the number and percentage of subjects by different study visit period, compare the efficacy differences among test groups and control groups. In addition, calculate the changes of NYHA cardiac functional grade from baseline of the subjects. The intragroup changes will be analyzed by signed-rank sum test, intergroup comparison will be conducted by Wilcoxon test.

    Measured: 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 posted3 Jan 2018
  2. Study start23 Jul 2018
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 2026 (estimated)

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388593
Sponsor's protocol ID
ZS-01-306
Status last verified
Jan 2024
First submitted
19 Dec 2017
Last updated
1 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 65 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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 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?

Results are not available in the source record.

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

Contact Xiaorui Wang, Ph.D (86-21-50802627 ext. 196, wangxiaorui@zensun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 1 year). 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 NCT03388593.

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 1 Feb 2024.

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