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

NCT ID: NCT06003972

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2023-03-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

guideline directed medical therapy (GDMT)

Intervention Type: DRUG

GDMT for heart failure according to the AHA guidelines.

Copaxone arm

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

Group Type: EXPERIMENTAL

Copaxone

Intervention Type: DRUG

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

Interventions

Copaxone

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

Intervention Type: DRUG

guideline directed medical therapy (GDMT)

GDMT for heart failure according to the AHA guidelines.

Intervention Type: DRUG

Other Intervention Names

Glatiramer Acetate

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weizmann Institute of Science

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

RABEA ASLEH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Offer Amir, PhD

Role: STUDY_DIRECTOR

Hadassah Medical Centre

Locations

Hadassah Ein Kerem medical center-hospital ,Cardiology Department

Jerusalem, , Israel

Countries

Israel

Other Identifiers

093418-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id