NCT06003972

Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Decompensated Heart Failure
• Cytokine Storm
• Inflammatory Response
• Heart Failure

Interventions

Type	Name	Description
DRUG	Copaxone	Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
DRUG	guideline directed medical therapy (GDMT)	GDMT for heart failure according to the AHA guidelines.

Timeline

• Start date: 2021-01-04
• Primary completion: 2023-03-12
• Completion: 2023-03-12
• First posted: 2023-08-22
• Last updated: 2023-08-22

Locations

1 site across 1 country: Israel