Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure.
NCT ID: NCT03388593
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1600 participants
INTERVENTIONAL
2018-07-23
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo in addition to standard therapy
Placebo
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
rhNRG-1
rhNRG-1 in addition to standard therapy
rhNRG-1
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
Interventions
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rhNRG-1
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
Placebo
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Zensun Sci. & Tech. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Runlin Gao, Ph.D,MD
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences
Locations
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Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Navy General Hospital
Beijing, Beijing Municipality, China
Beijing Jingmei Group General Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Affiliated Hospital of Chongqing Three Gorges Medical College
Chongqing, Chongqing Municipality, China
Chongqing Emergency Medical Center
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Sun Yai-sen Memorial hospital Sun Yai-sen University
Guangzhou, Guangdong, China
Guangdong Second Provincial Central Hospital
Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
Haikou People's Hospital
Haikou, Hainan, China
The Third People's Hospital of Hainan Province
Sanya, Hainan, China
HanDan Central Hospital
Handan, Hebei, China
First Hospital of Handan
Handan, Hebei, China
980 Hospital of PLA Joint Logistics Support Force (Bethune International Peace Hospital)
Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The First People's Hospital of Luoyang
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
The First People's Hospital of Xinxiang
Xinxiang, Henan, China
Pepole's hospital of Xinzheng
Xinzheng, Henan, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, China
Luoyang center hospital
Zhengzhou, Henan, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Second Hospital. University of South China
Hengyang, Hunan, China
The First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science & Technology
Baotou, Inner Mongolia, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Jiujiang Hospital Affiliated to Nanchang University
Jiujiang, Jiangxi, China
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, China
Jilin Academy of Traditional Chinese Medicine
Changchun, Jilin, China
Jilin University Sino-Japanese Friendship Hospital
Changchun, Jilin, China
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Meihekou Central Hospital
Meihekou, Jilin, China
Siping Central People's Hospital
Siping, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Central hospital of minhang District
Shanghai, Shanghai Municipality, China
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai Oriental hospital
Shanghai, Shanghai Municipality, China
Shanghai Yangpu District Central Hospital
Shanghai, Shanghai Municipality, China
The Central Hospital of Putuo District, Shanghai
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi cardiovascular disease hospital
Taiyuan, Shanxi, China
Taiyuan City Central Hospital
Taiyuan, Shanxi, China
Pepole's hospital of DeYang city
Deyang, Sichuan, China
The Second People's Hospital of Neijiang
Neijiang, Sichuan, China
Wuqing pepole's hospital
Tianjing, Tianjing, China
Fourth Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China
The Third People's Hospital of Yunnan Province
Kunming, Yunnan, China
The Second Hospital of Kunming Medical College
Kunming, Yunnan, China
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, China
Quzhou people's hospital
Quzhou, Zhejiang, China
Countries
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Central Contacts
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Runlin Gao, Ph.D,MD
Role: CONTACT
Facility Contacts
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Hongxu Liu
Role: primary
Tianchang Li
Role: primary
Jianping Luo
Role: primary
Jian Zhang, MD, Ph.D
Role: primary
Gang Xiong
Role: primary
Ying Zhang
Role: primary
Xiaohua Pang
Role: primary
Jingfeng Wang
Role: primary
Yuhui Li
Role: primary
Guoqin Chen
Role: primary
Jianying Chen
Role: primary
Xiufang Lin
Role: primary
Qianfeng Jiang
Role: primary
Shijuan Lu
Role: primary
Ling Lin
Role: primary
Hongsen Tian
Role: primary
Xiufeng Zhao
Role: primary
Ru Leisheng
Role: primary
Dongmei Gao
Role: primary
Qingmin Wei
Role: primary
Haifeng Shao
Role: primary
Ruili He
Role: primary
Qunsheng Zhang
Role: primary
Fuxian Ren
Role: primary
Guiye Zhao
Role: primary
Yanhong Li
Role: primary
Hongwei Yu
Role: primary
Shouyan Zhang
Role: primary
Juan Chen
Role: primary
Zaixin Yu
Role: primary
Jianqiang Peng
Role: primary
Gaofeng Zeng
Role: primary
Xuefeng Lin
Role: primary
Xiandong Sun
Role: primary
Yong Xia
Role: primary
Xihu Yin
Role: primary
Yue Deng
Role: primary
Shurong Liu
Role: primary
Fanbo Meng
Role: primary
Yushi Wang
Role: primary
Jinliang Zhang
Role: primary
Zhihua Fang
Role: primary
Xuxia Zhang
Role: primary
Zhanquan Li
Role: primary
Shumei Ma
Role: primary
Ling Chen
Role: primary
Wei Miao
Role: primary
Ming Zhong, MD,Ph.D
Role: primary
Wei Hu
Role: primary
Jingwei Pan
Role: primary
Huimin Fan
Role: primary
Jiahong Wang
Role: primary
Zongjun Liu, MD,Ph.D
Role: primary
Zhiming Yang
Role: primary
Huiyuan Han
Role: primary
Xiaojian Deng
Role: primary
Quanwei Liu
Role: primary
Feng Ling
Role: primary
Peng Li
Role: primary
Yunfei Hong
Role: primary
Wenwei Bai
Role: primary
Liping Ma
Role: primary
Jianjun Jiang
Role: primary
Xiaoming Tu
Role: primary
Other Identifiers
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ZS-01-306
Identifier Type: -
Identifier Source: org_study_id
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