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

NCT06003972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-08-22

No results posted yet for this study

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

Interventions

DRUG

Copaxone

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

DRUG

guideline directed medical therapy (GDMT)

GDMT for heart failure according to the AHA guidelines.

Sponsors & Collaborators

  • Weizmann Institute of Science

    collaborator OTHER

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Offer Amir, PhD · Hadassah Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2023-03-12
Completion
2023-03-12

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06003972 on ClinicalTrials.gov