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| Name | Class |
|---|---|
| Weizmann Institute of Science | OTHER |
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Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure.
Trial Design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | This arm serves as the control arm, patients allocated receive guideline directed medical therapy only |
|
| Copaxone arm | Experimental | Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copaxone | Drug | Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | %change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Prior hospitalizations or need of intravenous diuretic therapy in the last 30 days before current hospitalization
Cardiac co-morbidities:
Specific HF etiologies:
Complex congenital cardiac defect
New initiation of cardiac resynchronization therapy within 60 days prior to randomization
Life threatening arrhythmias /ICD ACTIVATION- in last 90 days Listing for heart transplantation or anticipated/implanted ventricular assist device
Non-cardiac co-morbidities:
Known Pregnancy Incapability of signing IC due to cognitive or mental reason Poor compliance to medical therapy or inability to complete the study Age >80 years
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| Name | Affiliation | Role |
|---|---|---|
| Offer Amir, PhD | Hadassah Medical Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Ein Kerem medical center-hospital ,Cardiology Department | Jerusalem | 911002 | Israel |
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| guideline directed medical therapy (GDMT) | Drug | GDMT for heart failure according to the AHA guidelines. |
|
| ID | Term |
|---|---|
| D000080424 | Cytokine Release Syndrome |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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