Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
NCT ID: NCT01131637
Last Updated: 2017-12-21
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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TERMINATED
PHASE3
331 participants
INTERVENTIONAL
2010-04-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rhNRG-1
recombinant human neuregulin-1
rhNRG-1
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion; week3\~week25:0.8ug/kg/day,10minutes per time per week for vein injection
placebo
placebo
placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion; week3\~week25:0.8ug/kg/day,10minutes per time per week for vein injection
Interventions
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rhNRG-1
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion; week3\~week25:0.8ug/kg/day,10minutes per time per week for vein injection
placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion; week3\~week25:0.8ug/kg/day,10minutes per time per week for vein injection
Eligibility Criteria
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Inclusion Criteria
2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
3. NYNA functional class III\~Ⅳ.
4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
5. Capable of signing the informed consent form.
Exclusion Criteria
2. Patients with right heart failure caused by pulmonary disease.
3. Patients diagnosed with pericardial effusion or pleural effusion.
4. Patients with myocardial infarction during the preceding 3 months.
5. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
6. Unstable angina pectoris.
7. Cardiac surgery or cerebrovascular accident within recent six months.
8. Preparing for heart transplantation.
9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
10. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr\>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
11. Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
12. Systolic blood pressure \<90mmHg or \>160mmHg.
13. Pregnant or plan to pregnant.
14. Patients who participated in any clinical trial in the recent three months.
15. Subject with a life expectancy less than 3 months as assessed by the investigator.
16. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
17. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
18. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
19. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
18 Years
80 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, MD,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute and Fuwai Hospital
Locations
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General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
The First Hospital affiliated to Lanzhou University
Lanzhou, Gansu, China
Haikou Municipal Peoples Hospital
Haikou, Hainan, China
Bethune International Peace Hospital
Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
Tianjin, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
The First hospital affiliated to Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuchang, Hubei, China
Tongji Hospital Affiliated to Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Jiangyin People's Hospital
Jiangyin, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
The Second Hospital affiliated to Suzhou University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical School
Xuzhou, Jiangsu, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Affiliate Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Second Hospital affiliated to Jilin University
Changchun, Jilin, China
The First Hospital affiliated to Dalian Medical University
Dalian, Liaoning, China
The first affiliated hospital of Liaoning medical college
Jinzhou, Liaoning, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The Second Hospital of Shandong University
Jinan, Shandong, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, China
The second hospital of Xi'an jiaotong university
Xi’an, Shanxi, China
Huaxi Hospital of Sichuan University
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Xinqiao Hospital of Third Military Medical University
Chongqin, Sichuan, China
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, China
The Second hospital affiliated to Kunming Medical and Pharmaceutical College
Kunming, Yunnan, China
Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The First Hospital affiliated to School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing, , China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, , China
Cardiovascular Institute and Fuwai Hospital
Beijing, , China
Huashan Hospital affiliated to Fudan University
Shanghai, , China
Renji Hospital, Medical School of Shanghai Jiaotong University
Shanghai, , China
The first people's hospitial of Shanghai
Shanghai, , China
The Sixth People's Hospital, Shanghai Jiaotong University
Shanghai, , China
Countries
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Other Identifiers
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ZS-01-301
Identifier Type: -
Identifier Source: org_study_id