Completed

NCT Number: NCT06003972

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Decompensated Heart Failure Cardiovascular Diseases Cytokine Release Syndrome Cytokine Storm Heart Diseases Heart Failure Inflammation Inflammatory Response Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hadassah Ein Kerem medical center-hospital ,Cardiology Department

Jerusalem, 911002, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Copaxone

Drug

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

Other names: Glatiramer Acetate

guideline directed medical therapy (GDMT)

Drug

GDMT for heart failure according to the AHA guidelines.

Primary outcomes

Primary Endpoint

Time frame: 3 weeks

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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

Weizmann Institute of Science

Registry information

Acronym: Copaxone

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Aug 22, 2023
Registry last updated: Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed