Could a common steroid speed heart shock recovery?
NCT ID NCT07461961
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests if giving a short course of steroids (methylprednisolone) for 7 days can help adults with heart failure who are in cardiogenic shock, a serious condition where the heart can't pump enough blood. The goal is to reduce harmful inflammation and help patients recover faster. About 30 people with high inflammation levels will take part, and researchers will track changes in inflammation and organ function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Exclusion Criteria: 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and women's hospital
Boston, Massachusetts, 02446, United States
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Other studies related to the condition(s) this trial covers.
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