Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
- Conditions
- Chronic Heart Failure
- Interventions
- Drug: rhNRG-1Drug: placebo
- Registration Number
- NCT01131637
- Lead Sponsor
- Zensun Sci. & Tech. Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
- Detailed Description
The mortality of chronic heart failure patients remains high, in spite of recent treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 331
- Age between 18 and 80, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class III~Ⅳ.
- Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
- Capable of signing the informed consent form.
- Patients with acute pulmonary edema or acute hemodynamic disorder.
- Patients with right heart failure caused by pulmonary disease.
- Patients diagnosed with pericardial effusion or pleural effusion.
- Patients with myocardial infarction during the preceding 3 months.
- Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
- Unstable angina pectoris.
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
- Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
- Serum potassium <3.2 mmol/L or >5.5 mmol/L.
- Systolic blood pressure <90mmHg or >160mmHg.
- Pregnant or plan to pregnant.
- Patients who participated in any clinical trial in the recent three months.
- Subject with a life expectancy less than 3 months as assessed by the investigator.
- Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
- History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
- 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.
- Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description rhNRG-1 rhNRG-1 recombinant human neuregulin-1 placebo placebo placebo
- Primary Outcome Measures
Name Time Method all cause mortality one year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Bethune International Peace Hospital
🇨🇳Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Hebei, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuchang, Hubei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The Affiliate Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, 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
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The First Hospital of China Medical Hospital
🇨🇳Shenyang, Liaoning, 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
🇨🇳Chendu, 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
Huashan Hospital affiliated to Fudan University
🇨🇳Shanghai, China
Renji Hospital, Medical School of Shanghai Jiaotong University
🇨🇳Shanghai, China
General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
The First Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
The First hospital affiliated to Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Tongji Hospital Affiliated to Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
Jiangsu Jiangyin People's Hospital
🇨🇳Jiangyin, Jiangsu, China
The Second Hospital affiliated to Suzhou University
🇨🇳Suzhou, Jiangsu, China
The Second Hospital affiliated to Jilin University
🇨🇳Changchun, Jilin, China
The Affiliated Hospital of Xuzhou Medical School
🇨🇳Xuzhou, Jiangsu, China
Sichuan Provincial People's Hospital
🇨🇳Chendu, Sichuan, China
Cardiovascular Institute and Fuwai Hospital
🇨🇳Beijing, China
Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The first people's hospitial of Shanghai
🇨🇳Shanghai, China
Haikou Municipal Peoples Hospital
🇨🇳Haikou, Hainan, China
The First Hospital affiliated to Lanzhou University
🇨🇳Lanzhou, Gansu, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
North Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
🇨🇳Beijing, China
The First Hospital affiliated to School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
🇨🇳Beijing, China
The Sixth People's Hospital, Shanghai Jiaotong University
🇨🇳Shanghai, China