The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cells to restore their structure and function. This study will investigate the safety and efficacy of rhNRG-1 to treat stable chronic heart failure.
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure. A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria. Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
Daily subcutaneous administration for 8 hours a day for 10 days
Daily subcutaneous administration for 8 hours a day for 10 days
Daily subcutaneous administration for 8 hours a day for 10 days
University of California, San Diego
La Jolla, California, United States
Metabolic Clinic and Research Center
Los Angeles, California, United States
USC Cardiovascular Division
Los Angeles, California, United States
Change from baseline in LVEF
Compared to baseline and placebo
Time frame: 30 days
Six (6) minute walk test
Compared to baseline and placebo
Time frame: Day 30, 90, 180, 365
Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire)
Compared to baseline and placebo
Time frame: Day 30, 90, 180 and 365
NYHA class status
Compared to baseline and placebo
Time frame: Day 30, 90, 180 and 365
All cause mortality and all cause hospitalization
Compared to baseline and placebo
Time frame: Days 30, 90, 180 and 365
Change in LVESV and LVEDV
Compared to baseline and placebo
Time frame: Day 30
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