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

What Was Tested

In this phase 2 trial, researchers set out to test Glatiramer Acetate.

Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure.

It had two arms (groups): Control (active comparator) and Copaxone arm (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 14 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: current hospitalization:; hemodynamic instability necessitating inotropic or mechanical circulatory support; respiratory failure necessitating invasive mechanical ventilation.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Glatiramer Acetate study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Glatiramer Acetate group and the comparison group ran side by side rather than switching.

Being open-label, the Glatiramer Acetate study did not mask who received what.

It started in 2021-01-04 with completion listed for 2023-03-12.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Primary Endpoint (time frame: 3 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glatiramer Acetate in 14 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, all human trials.