Chronic Heart Failure Clinical Trial
Official title:
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
Verified date | February 2012 |
Source | Zensun Sci. & Tech. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Status | Terminated |
Enrollment | 679 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age between 18 and 75, both sex. 2. Left ventricular ejection fraction (LVEF)=40% (ECHO). 3. NYNA functional class II OR III. 4. Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month. 5. 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. 6. Capable of signing the informed consent form. Exclusion Criteria: 1. new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months. 2. NYNA functional class I OR IV. 3. Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension. 4. Ischemic heart failure without recanalization or with recanalization in recent six months. 5. acute MI in the last 3 months. 6. unstable angina. 7. Patients with acute pulmonary edema or acute hemodynamic disorder. 8. Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month. 9. Patients with right heart failure caused by pulmonary disease. 10. Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml). 11. Cardiac surgery or cerebrovascular accident within recent six months. 12. Preparing for heart transplantation or CRT, or has received CRT. 13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate). 14. Serious hepatic or renal dysfunction (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit). 15. Serum potassium <3.2 mmol/L or >5.5 mmol/L. 16. Systolic blood pressure <90mmHg or >160mmHg. 17. Pregnant or plan to pregnant. 18. Patients who participated in any clinical trial in the recent three months. 19. Subject with a life expectancy less than 6 months as assessed by the investigator. 20. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute. 21. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia). 22. 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. 23. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others). |
Country | Name | City | State |
---|---|---|---|
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 | Cardiovascular Institute and Fuwai Hospital | Beijing | Beijing |
China | General Hospital of Chinese People's Liberation Army | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
China | The Second Hospital affiliated to Jilin University | Changchun | Jilin |
China | People's Hospital of Hunan Province | Changsha | Hunan |
China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
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 | Chongqing | Chongqing |
China | The First Hospital affiliated to Dalian Medical University | Dalian | Liaoning |
China | Daqing Oilfield General Hospital | Daqing | Heilongjiang |
China | Fujian Provincial Hospital | Fuzhou | Fujian |
China | Guangdong Provincial People's Hospital | Guangzhou | Guangdong |
China | The First Affiliated Hospital, Sun Yet-Sen University | Guangzhou | Guangdong |
China | The First Hospital of Harbin Medical University | Haerbin | Heilongjiang |
China | Haikou Municipal Peoples Hospital | Haikou | Hainan |
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 | Qilu Hospital of Shandong University | Jinan | Shandong |
China | The Second Hospital of Shandong University | Jinan | Shandong |
China | The first affiliated hospital of Liaoning medical college | Jinzhou | Liaoning |
China | Kunming General Hospital of Chengdu Military Region | Kunming | Yunnan |
China | The Second Hospital of Kunming Medical College | Kunming | Yunnan |
China | Nanjing Drum Tower Hospital | Nanjing | Jiangsu |
China | Zhongda Hospital, Southeast University | Nanjing | Jiangsu |
China | Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai |
China | Renji Hospital, Medical School of Shanghai Jiaotong University | Shanghai | Shanghai |
China | Ruijin Hospital, Medical School of Shanghai Jiaotong University | Shanghai | Shanghai |
China | The first people's hospitial of Shanghai | Shanghai | Shanghai |
China | The Sixth People's Hospital, Shanghai Jiaotong University | Shanghai | Shanghai |
China | The First Hospital of China Medical College | Shengyang | Liaoning |
China | Liaoning Provincial People's Hospital | Shenyang | Liaoning |
China | Shengjing Hospital of China Medical University | Shenyang | Liaoning |
China | Bethune Peace Hospital | Shijiazhuang | Hebei |
China | The Second Hospital affiliated to Suzhou University | Suzhou | Jiangsu |
China | The Second Hospital of Shanxi Medical College | Taiyuan | Shanxi |
China | Teda International Cardiovascular Hospital | Tianjin | Hebei |
China | Tongji Hospital Affiliated to Huazhong University of Science and Technology | Wuhan | Hubei |
China | The second hospital of Xi'an jiaotong university | Xi'an | Shanxi |
China | The Affiliated Hospital of Xuzhou Medical School | Xuzhou | Jiangsu |
China | North Jiangsu People's Hospital | Yangzhou | Jiangsu |
China | The First hospital affiliated to Zhengzhou University | Zhengzhou | Henan |
China | The Affiliate Hospital of Jiangsu University | Zhenjiang | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Zensun Sci. & Tech. Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | 1 year | ||
Secondary | sudden death | 1 year | ||
Secondary | death caused by cardiovascular events | 1 year | ||
Secondary | rehospitalization | 1 year | ||
Secondary | hospitalization caused by worsening heart failure | 1 year | ||
Secondary | cardiac function | 1 year | ||
Secondary | NYHA functional classification | 1 year | ||
Secondary | 6 minute walking distance | 1 year | ||
Secondary | quality of life | 1 year |
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