Status:
COMPLETED
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Weizmann Institute of Science
Conditions:
Acute Decompensated Heart Failure
Cytokine Storm
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 hospit...
Eligibility Criteria
Inclusion
- STAGE CHF BASELINE NYHA functional class II-III and established diagnosis of ischemic cardiomyopathy
- Hospitalization due to acute decompensated CHF
- GDMT for at least 3 months prior to enrollment
Exclusion
- Current hospitalization:
- Hemodynamic instability necessitating inotropic or mechanical circulatory support
- Respiratory failure necessitating invasive mechanical ventilation
- Active infection
- A different etiology to explain SIRS other than CHF exacerbation.
- Prior hospitalizations or need of intravenous diuretic therapy in the last 30 days before current hospitalization
- Cardiac co-morbidities:
- Specific HF etiologies:
- Pericardial disease
- Infiltrative myocardial disease
- Moderate and above Valvular heart disease Acute coronary syndrome in the preceding 60 days to randomization Evidence of significant cardiac ischemia within 1 year of randomization without revascularization since Stroke or TIA in the preceding 30 days from randomization
- 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:
- Glomerular filtration rate \<30 mL/min/1.73m2 calculated by MDRD formula
- Hepatic insufficiency classified as Child-Pugh B or C
- SBP \>180 mm Hg or \<110 mm Hg NOT RESPONSIVE TO THERAPY
- Morbid obesity with a BMI \>40 kg/m2
- Severe pulmonary disease with requirement of home oxygen therapy or important nocturnal desaturation
- Active treatment for malignancy in the past 2 years or neoplastic spread beyond organ of origin (lymphatic metastases included)
- Hemoglobin \<8 g/dL
- Known previous systemic inflammatory disease
- Alcohol or drug abuse Chronic treatment with Copaxone, cytotoxic, immunosuppressant or biological treatment in the past two years.
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06003972
Start Date
January 4 2021
End Date
March 12 2023
Last Update
August 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hadassah Ein Kerem medical center-hospital ,Cardiology Department
Jerusalem, Israel, 911002