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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Methylprednisone
DrugIntravenous methylprednisolone administered as an adjunctive therapy to target systemic inflammation. The dosing regimen is 80 mg IV once daily for 3 days, followed by a taper of 0.5 mg/kg/day for 4 additional days (total of 7 days). This regimen aims to provide potent early anti-inflammatory effects while minimizing fluid retention and adverse events
Standard of Care (SOC)
Other interventionRoutine medical care and management for heart failure-related cardiogenic shock, which may include vasoactive medications and temporary mechanical circulatory support (tMCS) per institutional protocols.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Methylprednisolone plus Standard of CareExperimental treatment 1 intervention
Group B: Standard of Care (Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration
The primary outcome is the change in hsCRP concentration, which serves as a biomarker-based measure of systemic inflammation to evaluate corticosteroid-mediated inflammatory modulation. To account for the pharmacokinetics of methylprednisolone, a 12-hour blanking period will be imposed; clinical outcomes occurring within the first 12 hours after treatment initiation will not be considered in the analysis
Time frame
Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU dischargeSecondary outcomes
1
Change in Interleukin-6 (IL-6) Concentration
Serial measurements of key inflammatory biomarkers, including IL-6, will be performed to assess the mechanistic impact of corticosteroid therapy on inflammation.
Time frame
Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge2
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and High-sensitivity troponin T (hs-TnT)Concentration
Serial measurements of NT-proBNP and hs-TnT will be performed to assess cardiac biomarker trajectories
Time frame
Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge3
Temporal Trends in Vasoactive Inotropic Score (VIS)
The VIS will be analyzed to assess hemodynamic recovery and the requirement for vasoactive support. The peak VIS, duration of high-dose vasoactive support, and sustained high-dose vasoactive requirement (VIS ≥40 or an increase of ≥10 points from baseline sustained for ≥6 hours) will be recorded
Time frame
Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge4
Escalation of Device Therapy
Escalation of device therapy is defined as progression from an intra-aortic balloon pump (IABP) to a microaxial flow pump or venoarterial extracorporeal membrane oxygenation (VA-ECMO). The type of device, timing of escalation, and duration of support will be recorded
Time frame
Through study completion, an average of 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: