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

NCT07461961 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025P002774
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammation; Cardiogenic Shock; Heart Failure

Keywords

cardiogenic shock; heart failure cardiogenic shock; inflammation; corticosteroids

Outcome Measures

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

  Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge

Secondary Outcomes (7)

• Change in Interleukin-6 (IL-6) Concentration

  Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge

• Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and High-sensitivity troponin T (hs-TnT)Concentration

  Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge

• Temporal Trends in Vasoactive Inotropic Score (VIS)

  Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge

• Escalation of Device Therapy

  Through study completion, an average of 30 days

• Successful Device Weaning

  Through study completion, an average of 30 days

Study Arms (2)

Methylprednisolone plus Standard of Care

EXPERIMENTAL

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

Drug: Methylprednisone

Standard of Care (Control)

ACTIVE COMPARATOR

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

Other: Standard of Care (SOC)

Interventions

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.

Standard of Care (Control)

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

Methylprednisolone plus Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and women's hospital

Boston, Massachusetts, 02446, United States

Location

Related Publications (1)

• Isath A, Desai AS, Mehra MR. Beyond the Pump: Reframing Cardiogenic Shock in Heart Failure Through a Multisystem Mechanistic Lens. JACC Heart Fail. 2026 Jan;14(1):102711. doi: 10.1016/j.jchf.2025.102711. Epub 2025 Oct 16.

  PMID: 41099686 BACKGROUND

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure; Inflammation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ameesh M Isath, MBBS

CONTACT

617-525-7053; aisath@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Model Details: Thirty adult patients with SCAI Stage B or C HF-CS and LVEF \<40% will be randomized in a 1:1 ratio within 24 hours of admission to receive either standard of care (SoC) or SoC plus a short course of intravenous methylprednisolone. The randomization uses an adaptive restricted procedure ("biased coin design") to balance group assignments

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)