Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
- Conditions
- Chronic Heart Failure
- Interventions
- Drug: PlaceboDrug: rhNRG-1
- Registration Number
- NCT01541202
- 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 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 trial and phase II clinical trail 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. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 679
- Age between 18 and 75, both sex.
- Left ventricular ejection fraction (LVEF)≤40% (ECHO).
- NYNA functional class II OR III.
- Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
- Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
- Capable of signing the informed consent form.
- new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
- NYNA functional class I OR IV.
- Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
- Ischemic heart failure without recanalization or with recanalization in recent six months.
- acute MI in the last 3 months.
- unstable angina.
- Patients with acute pulmonary edema or acute hemodynamic disorder.
- Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
- Patients with right heart failure caused by pulmonary disease.
- Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
- Cardiac surgery or cerebrovascular accident within recent six months.
- Preparing for heart transplantation or CRT, or has received CRT.
- Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
- Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 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 6 months as assessed by the investigator.
- Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
- 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 Placebo Placebo placebo in addition to standard therapy rhNRG-1 rhNRG-1 rhNRG-1 in addition to standard therapy
- Primary Outcome Measures
Name Time Method All-cause mortality 1 year
- Secondary Outcome Measures
Name Time Method death caused by cardiovascular events 1 year rehospitalization 1 year hospitalization caused by worsening heart failure 1 year cardiac function 1 year sudden death 1 year 6 minute walking distance 1 year quality of life 1 year NYHA functional classification 1 year
Trial Locations
- Locations (46)
People's Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
The first affiliated hospital of Liaoning medical college
🇨🇳Jinzhou, Liaoning, China
The First Affiliated Hospital, Sun Yet-Sen University
🇨🇳Guangzhou, Guangdong, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Haikou Municipal Peoples Hospital
🇨🇳Haikou, Hainan, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Liaoning Provincial People's Hospital
🇨🇳Shenyang, Liaoning, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
The Second Hospital affiliated to Suzhou University
🇨🇳Suzhou, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
North Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Xuanwu hospital of Capital Medical University
🇨🇳Beijing, Beijing, China
The Xinqiao Hospital of Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Bethune Peace Hospital
🇨🇳Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
🇨🇳Tianjin, Hebei, China
The First Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Tongji Hospital Affiliated to Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First hospital affiliated to Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Zhongda Hospital, Southeast University
🇨🇳Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical School
🇨🇳Xuzhou, Jiangsu, China
The Affiliate Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The First Hospital affiliated to Dalian Medical University
🇨🇳Dalian, Liaoning, China
The First Hospital of China Medical College
🇨🇳Shengyang, Liaoning, China
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Huashan Hospital affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Renji Hospital, Medical School of Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
The first people's hospitial of Shanghai
🇨🇳Shanghai, Shanghai, China
The Second Hospital of Shanxi Medical College
🇨🇳Taiyuan, Shanxi, China
The second hospital of Xi'an jiaotong university
🇨🇳Xi'an, Shanxi, China
The Sixth People's Hospital, Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Huaxi Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The Second Hospital of Kunming Medical College
🇨🇳Kunming, Yunnan, China
General Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Cardiovascular Institute and Fuwai Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Second Hospital affiliated to Jilin University
🇨🇳Changchun, Jilin, China
Ruijin Hospital, Medical School of Shanghai Jiaotong University
🇨🇳Shanghai, Shanghai, China
Kunming General Hospital of Chengdu Military Region
🇨🇳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