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

Starting soon · Phase 2

Conditions studied: Cardiogenic Shock, Heart Failure, Inflammation

In brief

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 facts

Study ID

NCT07461961

Run by

Brigham and Women's Hospital

People needed

30

Starts

2026-07-01

Expected to finish

2029-02-01

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 and ≤ 80 years.
• Hospitalized in the Intensive Care Unit (ICU).
• Cardiogenic shock defined by clinical and hemodynamic criteria.
• Hypotension defined by SBP <90 mmHg for >30 min, MAP <60 mmHg for >30 min, or requirement of vasopressors to maintain SBP ≥90 mmHg or MAP ≥60 mm Hg.
• Hypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output <30 mL/h, or lactate ≥2 mmol/L.
• If invasive hemodynamic monitoring is available, CI <2.2 L/min/m2.
• SCAI stage B or stage C at the time of screening.
• For SCAI Stage B (Beginning Shock), clinical evidence of hemodynamic instability (including relative hypotension, a decline in SBP of ≥20-30 mmHg, or MAP <20% from baseline, or tachycardia) without hypoperfusion (normal lactate).
• For SCAI Stage B, hypotension SBP <90 mmHg or MAP <60 mmHg or > 30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm.
• For SCAI Stage C, requiring only one vasoactive/inotrope and/or IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) <40.
• For SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization: failure to respond to initial single vasopressor/inotrope drug and addition of a second drug, or failure to respond to IABP and need for new MCS device.
• For SCAI Stage C, use of vasoactive agents at the time of randomization must not show: low starting dose with escalation, intermediate starting dose without escalation or de-escalation, or high starting dose with de-escalation.
• For SCAI Stage C, worst lactate 2 - 5 mmol/L and increase ≥ 100% from baseline lactate ≥ 2mmol/L or worst lactate ≥5mmol/L.
• Documented history of chronic heart failure with reduced ejection fraction (LVEF <40%).
• Etiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).
• hsCRP ≥20 mg/L, reflecting a pro-inflammatory state.
• Less than 48 hours since admission

You may not qualify if…

• Cardiogenic shock caused by acute myocardial infarction (AMI-CS).
• Other special conditions causing cardiogenic shock, including post-cardiotomy CS, peripartum, adrenergic, valvular, restrictive, post-embolic, conduction or rhythm disorders, or related to cardiotropic drug intoxication.
• Circulatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.
• Shock post-cardiac arrest.
• Onset of cardiogenic shock >48 hours.
• SCAI stage A, D, or E at the time of enrollment.
• Severe hyperglycemia at baseline, defined as blood glucose ≥300 mg/dL despite insulin therapy.
• Ongoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.
• Ischemic hepatitis or ALT >500 IU/L due to causes other than suspected hypoperfusion.
• Severe refractory acute kidney injury (AKI) at baseline, defined as new persistent anuria (urine output <50 mL/day) or refractory AKI requiring new emergent renal replacement therapy.
• Known allergy to methylprednisolone or other steroid analogues.
• Cardiac transplant patient or on the transplant list.
• Patient planned for implantation of a durable LVAD.
• Moribund patients (SAPS2 >90) or predicated mortality >90% within 30 days.
• Signs of extremis, including lactate >5 mmol/L, pH <7.2, or refractory shock requiring escalation to >3 vasopressors at screening.
• Pregnant woman, parturient, or breastfeeding mother.
• Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).

Where it is running

• Brigham and women's hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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