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

Primary Purpose

Acute Decompensated Heart Failure, Cytokine Storm, Inflammatory Response

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Copaxone
guideline directed medical therapy (GDMT)
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Ein Kerem medical center-hospital ,Cardiology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Copaxone arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
August 15, 2023
Sponsor
Hadassah Medical Organization
Collaborators
Weizmann Institute of Science
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1. Study Identification

Unique Protocol Identification Number
NCT06003972
Brief Title
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
Acronym
Copaxone
Official Title
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
March 12, 2023 (Actual)
Study Completion Date
March 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Weizmann Institute of Science

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure, Cytokine Storm, Inflammatory Response, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
This arm serves as the control arm, patients allocated receive guideline directed medical therapy only
Arm Title
Copaxone arm
Arm Type
Experimental
Arm Description
Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days
Intervention Type
Drug
Intervention Name(s)
Copaxone
Other Intervention Name(s)
Glatiramer Acetate
Intervention Description
Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
Intervention Type
Drug
Intervention Name(s)
guideline directed medical therapy (GDMT)
Intervention Description
GDMT for heart failure according to the AHA guidelines.
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
%change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Offer Amir, PhD
Organizational Affiliation
Hadassah Medical Centre
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Ein Kerem medical center-hospital ,Cardiology Department
City
Jerusalem
ZIP/Postal Code
911002
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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