Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure. Trial Design * An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction. * Patients will be enrolled within 24 hours from hospital admission. * Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission). * Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone. * Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days. * Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring". * Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points. * The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
GDMT for heart failure according to the AHA guidelines.
Hadassah Ein Kerem medical center-hospital ,Cardiology Department
Jerusalem, Israel
Primary Endpoint
%change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups
Time frame: 3 weeks
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