Clinical Trial: Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Zensun Sci. & Tech. Co., Ltd.
Current Primary Outcome: Left Ventricular Ejection Fraction [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Left Ventricular Ejection Fraction [ Time Frame: 90 days ]
- N-terminal pro-BNP [ Time Frame: 30 days and 90 days ]
Original Secondary Outcome: Same as current
Information By: Zensun Sci. & Tech. Co., Ltd.
Dates:
Date Received: September 21, 2011
Date Started: June 2011
Date Completion: December 2012
Last Updated: August 1, 2012
Last Verified: July 2012
