CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrigham and Women's Hospital

About this trial

This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock. Heart failure-related cardiogenic shock happens when chronic heart dysfunction causes poor blood circulation and congestion throughout the body. Often, this condition triggers severe inflammation, making it harder for the heart and other organs to recover, even when temporary mechanical heart pumps are used to support blood flow.

The study aims to see if reducing this inflammation with corticosteroids is safe and can help patients get better faster. Researchers will enroll 30 adult patients hospitalized with early-stage (SCAI Stage B or C) cardiogenic shock related to heart failure. To participate, patients must also show high levels of inflammation in their blood, specifically a high-sensitivity C-reactive protein (hsCRP) level of 20 mg/L or higher

Participants will be randomly assigned by chance to one of two groups. One group will receive the standard of care alone. The other group will receive the standard of care plus a 7-day course of intravenous methylprednisolone.

The main goal of the study is to measure the change in inflammation levels (hsCRP) over 7 days. Researchers will also monitor how well the patients' organs recover, track their need for blood pressure medications or mechanical heart pumps, and monitor for any side effects to ensure the treatment is safe

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Methylprednisone
  • Standard of Care (SOC)

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators