This is a multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart failure.
RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling and is tolerated in patients with chronic heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
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
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality, China
General Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Left Ventricular Ejection Fraction
Time frame: 30 days
Left Ventricular Ejection Fraction
Time frame: 90 days
N-terminal pro-BNP
Time frame: 30 days and 90 days
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