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

Heart Failure Clinical Trial

— Copaxone  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003972
• Other study ID #: 093418-HMO-CTIL
• Status: Completed
• Phase: Phase 2
• Start date: January 4, 2021
• Est. completion date: March 12, 2023

Study information

• Verified date: August 2023
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 12, 2023
• Est. primary completion date: March 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Cytokine Release Syndrome
• Cytokine Storm
• Heart Failure
• Inflammatory Response

Intervention

Drug:
• Copaxone
Paptients allocated to this arm receive 20 mg GA given s.c daily for a total of 14 days
• guideline directed medical therapy (GDMT)
GDMT for heart failure according to the AHA guidelines.

Locations

Country	Name	City	State
Israel	Hadassah Ein Kerem medical center-hospital ,Cardiology Department	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Weizmann Institute of Science

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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