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

Conditions

• Cardiogenic Shock
• Heart Failure
• Inflammation

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Methylprednisone — DRUG
  Intravenous 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
  Routine medical care and management for heart failure-related cardiogenic shock, which may include vasoactive medications and temporary mechanical circulatory support (tMCS) per institutional protocols.

Study Details

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

Key Dates

Start date

Jul 1, 2026

Status verified

Mar 2026

Primary completion

Feb 1, 2028

Completion

Feb 1, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Methylprednisolone plus Standard of Care
  Participants randomized to this intervention arm will receive standard of care (SoC) along with a short course of intravenous methylprednisolone. The methylprednisolone will be administered at a dose of 80 mg IV once daily for 3 days, followed by a taper of 0.5 mg/kg/day for 4 additional days, for a total of 7 days of therapy
• Active Comparator: Standard of Care (Control)
  Participants randomized to this control arm will receive current best practices and standard of care (SoC) alone for the management of SCAI Stage B or C cardiogenic shock. They will not receive the investigational methylprednisolone therapy

Primary Outcome Measure

Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration [ Time Frame: Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge ]

Central Contacts

• Ameesh M Isath, MBBS
  617-525-7053
  [email protected]

Locations (1)

Find similar trials in Boston, MA

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