Study Stopped
Sponsor has designed another study to replace the current study
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
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
1 other identifier
interventional
331
1 country
43
Brief Summary
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2010
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedDecember 21, 2017
July 1, 2012
2.2 years
May 25, 2010
December 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all cause mortality
one year
Study Arms (2)
rhNRG-1
EXPERIMENTALrecombinant human neuregulin-1
placebo
PLACEBO COMPARATORplacebo
Interventions
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
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
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
Study Officials
- PRINCIPAL INVESTIGATOR
Runlin Gao, MD,Ph.D
Cardiovascular Institute and Fuwai Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 27, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
December 21, 2017
Record last verified: 2012-07