[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628463":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fkg\u002Fday for 4 additional days, for a total of 7 days of therapy",[13],"Drug: Methylprednisone",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Other: Standard of Care (SOC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methylprednisone","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\u002Fkg\u002Fday 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",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard of Care (SOC)","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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ameesh M Isath, MBBS","CONTACT","617-525-7053","aisath@bwh.harvard.edu",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Brigham and women's hospital","Boston","Massachusetts","02446","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ameesh Isath","Instructor of Medicine","100628463","phase-2-cortishock-p-trial-of-corticosteroids-in-inflammation-enriched-heart-failure-cardiogenic-shock-100628463",false,"NCT07461961","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","CORTISHOCK-P","Inclusion Criteria:\n\nAge ≥ 18 and ≤ 80 years.\n\nHospitalized in the Intensive Care Unit (ICU).\n\nCardiogenic shock defined by clinical and hemodynamic criteria.\n\nHypotension defined by SBP \\\u003C90 mmHg for \\>30 min, MAP \\\u003C60 mmHg for \\>30 min, or requirement of vasopressors to maintain SBP ≥90 mmHg or MAP ≥60 mm Hg.\n\nHypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output \\\u003C30 mL\u002Fh, or lactate ≥2 mmol\u002FL.\n\nIf invasive hemodynamic monitoring is available, CI \\\u003C2.2 L\u002Fmin\u002Fm2.\n\nSCAI stage B or stage C at the time of screening.\n\nFor SCAI Stage B (Beginning Shock), clinical evidence of hemodynamic instability (including relative hypotension, a decline in SBP of ≥20-30 mmHg, or MAP \\\u003C20% from baseline, or tachycardia) without hypoperfusion (normal lactate).\n\nFor SCAI Stage B, hypotension SBP \\\u003C90 mmHg or MAP \\\u003C60 mmHg or \\> 30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm.\n\nFor SCAI Stage C, requiring only one vasoactive\u002Finotrope and\u002For IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) \\\u003C40.\n\nFor SCAI Stage C, NONE of the following criteria of deterioration from admission until randomization: failure to respond to initial single vasopressor\u002Finotrope drug and addition of a second drug, or failure to respond to IABP and need for new MCS device.\n\nFor 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.\n\nFor SCAI Stage C, worst lactate 2 - 5 mmol\u002FL and increase ≥ 100% from baseline lactate ≥ 2mmol\u002FL or worst lactate ≥5mmol\u002FL.\n\nDocumented history of chronic heart failure with reduced ejection fraction (LVEF \\\u003C40%).\n\nEtiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).\n\nhsCRP ≥20 mg\u002FL, reflecting a pro-inflammatory state.\n\nLess than 48 hours since admission\n\nExclusion Criteria:\n\nCardiogenic shock caused by acute myocardial infarction (AMI-CS).\n\nOther 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.\n\nCirculatory shock of another cause, such as septic, hemorrhagic, or anaphylactic shock.\n\nShock post-cardiac arrest.\n\nOnset of cardiogenic shock \\>48 hours.\n\nSCAI stage A, D, or E at the time of enrollment.\n\nSevere hyperglycemia at baseline, defined as blood glucose ≥300 mg\u002FdL despite insulin therapy.\n\nOngoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.\n\nIschemic hepatitis or ALT \\>500 IU\u002FL due to causes other than suspected hypoperfusion.\n\nSevere refractory acute kidney injury (AKI) at baseline, defined as new persistent anuria (urine output \\\u003C50 mL\u002Fday) or refractory AKI requiring new emergent renal replacement therapy.\n\nKnown allergy to methylprednisolone or other steroid analogues.\n\nCardiac transplant patient or on the transplant list.\n\nPatient planned for implantation of a durable LVAD.\n\nMoribund patients (SAPS2 \\>90) or predicated mortality \\>90% within 30 days.\n\nSigns of extremis, including lactate \\>5 mmol\u002FL, pH \\\u003C7.2, or refractory shock requiring escalation to \\>3 vasopressors at screening.\n\nPregnant woman, parturient, or breastfeeding mother.\n\nAdult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice).","ALL","18 Years","80 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","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.\n\nThe 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\u002FL or higher\n\nParticipants 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.\n\nThe 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",[76,77,78],"Cardiogenic Shock","Heart Failure","Inflammation",[80,81,82,83],"cardiogenic shock","heart failure cardiogenic shock","inflammation","corticosteroids","NOT_YET_RECRUITING","2026-08-11",{"date":87,"type":88},"2026-08-13","ACTUAL",{"date":90,"type":70},"2026-10-01",{"date":92,"type":70},"2029-02-01",{"name":5,"class":6},1]