Not yet recruitingPhase 2

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

CORTISHOCK-P: A Randomized Pilot Trial of Corticosteroids as a Pharmacologic Adjunct to Temporary Mechanical Circulatory Support in Inflammation-Enriched Heart Failure Cardiogenic Shock

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 days, 3 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The main goal of the study is to measure the change in inflammation levels (hsCRP) over 7 days."
  • "The pharmacological intervention consists of methylprednisolone administered at 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 duration of 7 days."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a steroid medicine called methylprednisolone can safely lower inflammation and help people recover from shock caused by heart failure. It is for adults in intensive care with early-stage shock and high inflammation in their blood. Patients will be assigned by chance to usual care alone or usual care plus the steroid given through a vein for 7 days.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 80 and admitted to the intensive care unit (ICU) less than 48 hours ago.
  • Have long-term heart failure with a weak heart pump: the heart pumps out less than 40% of its blood with each beat.
  • Have shock caused by worsening heart failure, meaning the heart cannot move enough blood through the body.
  • Have early-stage shock, called SCAI stage B or C, and meet the study’s blood pressure and blood flow rules.
  • For stage B, have low or falling blood pressure or a fast heartbeat, without signs that organs are getting too little blood.
  • For stage C, meet strict rules for medicines that support blood pressure or heart pumping, heart pump devices, treatment response, and blood lactate levels.
  • Have an hsCRP blood test result of at least 20 mg/L, showing high inflammation.

Who can't join

  • Shock caused by a heart attack, heart surgery, pregnancy-related heart disease, certain other heart problems, heart medicine poisoning, infection, bleeding, or a severe allergic reaction; or shock after the heart stopped.
  • Shock that started more than 48 hours ago, or SCAI stage A, D, or E.
  • Blood sugar of at least 300 mg/dL despite insulin; an uncontrolled infection; or suspected sepsis, a dangerous response to infection.
  • Certain severe liver problems, or severe new kidney failure with almost no urine or a need for urgent dialysis to clean the blood.
  • An allergy to methylprednisolone or similar steroids; a heart transplant or a place on the transplant list; or plans for a long-term heart pump.
  • Near death or a predicted chance of death above 90% within 30 days; or signs of extreme illness, such as lactate above 5 mmol/L, blood pH below 7.2, or a need to increase treatment to more than 3 blood pressure medicines.
  • Pregnant, giving birth, or breastfeeding.
  • Under a legal protection order, such as guardianship.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (1)

MA