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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06003972
Study type Interventional
Source Hadassah Medical Organization
Contact
Status Completed
Phase Phase 2
Start date January 4, 2021
Completion date March 12, 2023

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