Clinical trial NCT01541202: Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
neuregulin
mortality
Lead sponsor: Zensun Sci. & Tech. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: All-cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: sudden death
timeFrame: 1 year
measure: death caused by cardiovascular events
timeFrame: 1 year
measure: rehospitalization
timeFrame: 1 year
measure: hospitalization caused by worsening heart failure
timeFrame: 1 year
measure: cardiac function
timeFrame: 1 year
measure: NYHA functional classification
timeFrame: 1 year
measure: 6 minute walking distance
timeFrame: 1 year
measure: quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Xuanwu hospital of Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Chongqing
country: China
facility: The Xinqiao Hospital of Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yet-Sen University
state: Guangdong
city: Haikou
country: China
facility: Haikou Municipal Peoples Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Bethune Peace Hospital
state: Hebei
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Haerbin
country: China
facility: The First Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First hospital affiliated to Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: People's Hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Hospital affiliated to Suzhou University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical School
state: Jiangsu
city: Yangzhou
country: China
facility: North Jiangsu People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliate Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital affiliated to Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Hospital affiliated to Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: The first affiliated hospital of Liaoning medical college
state: Liaoning
city: Shengyang
country: China
facility: The First Hospital of China Medical College
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Provincial People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Medical School of Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Medical School of Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: The first people's hospitial of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: The Sixth People's Hospital, Shanghai Jiaotong University
state: Shanghai
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical College
state: Shanxi
city: Xi'an
country: China
facility: The second hospital of Xi'an jiaotong university
state: Shanxi
city: Chengdu
country: China
facility: Huaxi Hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Kunming
country: China
facility: Kunming General Hospital of Chengdu Military Region
state: Yunnan
city: Kunming
country: China
facility: The Second Hospital of Kunming Medical College
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Hospital affiliated to School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital
name: Runlin Gao, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: