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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Completed
CT.gov ID
NCT06003972
Collaborator
Weizmann Institute of Science (Other)
14
Enrollment
1
Location
2
Arms
26.2
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
Actual Study Start Date :
Jan 4, 2021
Actual Primary Completion Date :
Mar 12, 2023
Actual Study Completion Date :
Mar 12, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control

This arm serves as the control arm, patients allocated receive guideline directed medical therapy only

Drug: guideline directed medical therapy (GDMT)
GDMT for heart failure according to the AHA guidelines.
Experimental: Copaxone arm

Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days

Drug: Copaxone
Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
Other Names:
  • Glatiramer Acetate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Endpoint [3 weeks]

      %change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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 Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah Ein Kerem medical center-hospital ,Cardiology Department Jerusalem Israel 911002

    Sponsors and Collaborators

    • Hadassah Medical Organization
    • Weizmann Institute of Science

    Investigators

    • Study Director: Offer Amir, PhD, Hadassah Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RABEA ASLEH, Professor, Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT06003972
    Other Study ID Numbers:
    • 093418-HMO-CTIL
    First Posted:
    Aug 22, 2023
    Last Update Posted:
    Aug 22, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Cytokine Release Syndrome
    Glatiramer Acetate
    (T,G)-A-L

    Study Results

    No Results Posted as of Aug 22, 2023