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Copaxone in Acute Decompensated Heart Failure
NCT06003972Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2021
- Primary completion
- Mar 2023
- Countries
- 1
- Sponsor
- Hadassah Medical Organization
- Modality
- Peptides, Recombinant Proteins and Enzymes
- Drugs
- glatiramer acetate
- Conditions
- heart failure (HF)
01
Overview
Phase 2, randomised, open-label trial of glatiramer acetate in heart failure (HF) (2 arms), sponsored by Hadassah Medical Organization. Primary endpoint: Changes in inflammatory cytokines at Day 30. Started Jan 2021; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Control
Guideline Directed Medical Therapy (GDMT) only
Copaxone arm
GDMT + Copaxone 20 mg SC daily
03
Who it enrols
Patients with NYHA class II-III ischemic cardiomyopathy hospitalized for acute decompensated heart failure, on GDMT for at least 3 months. Excludes patients with hemodynamic instability, respiratory failure, active infection, severe renal or hepatic insufficiency, or BMI > 40.
04
Endpoints
Primary
Changes in inflammatory cytokines
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