The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
679
10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
All-cause mortality
Time frame: 1 year
sudden death
Time frame: 1 year
death caused by cardiovascular events
Time frame: 1 year
rehospitalization
Time frame: 1 year
hospitalization caused by worsening heart failure
Time frame: 1 year
cardiac function
Time frame: 1 year
NYHA functional classification
Time frame: 1 year
6 minute walking distance
Time frame: 1 year
quality of life
Time frame: 1 year
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Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing Municipality, China
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General Hospital of Chinese People's Liberation Army
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Peking University First Hospital
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The Xinqiao Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yet-Sen University
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...and 36 more locations