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

Hadassah Medical Center

Status and phase

Completed

Phase 2

Conditions

Inflammatory Response

Cytokine Storm

Acute Decompensated Heart Failure

Heart Failure

Treatments

Drug: Copaxone

Drug: guideline directed medical therapy (GDMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06003972

093418-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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