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

NCT06003972 | Completed Phase 2 DMC

• 1 other identifier: 093418-HMO-CTIL
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure; Cytokine Storm; Inflammatory Response; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: guideline directed medical therapy (GDMT)

Copaxone arm

EXPERIMENTAL

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

Drug: Copaxone

Interventions

Copaxone DRUG

Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days

Also known as: Glatiramer Acetate

Copaxone arm

guideline directed medical therapy (GDMT) DRUG

GDMT for heart failure according to the AHA guidelines.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Hadassah Ein Kerem medical center-hospital ,Cardiology Department

Jerusalem, 911002, Israel

Location

MeSH Terms

Conditions

Cytokine Release Syndrome; Heart Failure

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Offer Amir, PhD

  Hadassah Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: January 4, 2021
• Primary Completion: March 12, 2023
• Study Completion: March 12, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IL (1)