Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:58 AM
Study NCT ID:
NCT07461961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in High-Sensitivity C-Reactive Protein (hsCRP) Concentration', 'timeFrame': 'Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in Interleukin-6 (IL-6) Concentration', 'timeFrame': 'Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge', 'description': 'Serial measurements of key inflammatory biomarkers, including IL-6, will be performed to assess the mechanistic impact of corticosteroid therapy on inflammation.'}, {'measure': 'Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) and High-sensitivity troponin T (hs-TnT)Concentration', 'timeFrame': 'Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge', 'description': 'Serial measurements of NT-proBNP and hs-TnT will be performed to assess cardiac biomarker trajectories'}, {'measure': 'Temporal Trends in Vasoactive Inotropic Score (VIS)', 'timeFrame': 'Baseline, 24, 48, 72, and 96 hours, and at day 7 or ICU discharge', 'description': 'The VIS will be analyzed to assess hemodynamic recovery and the requirement for vasoactive support. The peak VIS, duration of high-dose vasoactive support, and sustained high-dose vasoactive requirement (VIS ≥40 or an increase of ≥10 points from baseline sustained for ≥6 hours) will be recorded'}, {'measure': 'Escalation of Device Therapy', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'Escalation of device therapy is defined as progression from an intra-aortic balloon pump (IABP) to a microaxial flow pump or venoarterial extracorporeal membrane oxygenation (VA-ECMO). The type of device, timing of escalation, and duration of support will be recorded'}, {'measure': 'Successful Device Weaning', 'timeFrame': 'Through study completion, an average of 30 days', 'description': 'Successful device weaning is defined as the removal of temporary mechanical circulatory support (tMCS) without the recurrence of hemodynamic instability within 48 hours.'}, {'measure': 'Lactate Clearance', 'timeFrame': '6, 12, 24, and 48 hours', 'description': 'Lactate clearance is defined as the relative reduction in serum lactate levels compared to baseline. Persistent hyperlactatemia (lactate ≥3.0 mmol/L) or failure to achieve \\>50% lactate clearance at 24 hours will be analyzed as markers of impaired metabolic recovery and tissue hypoperfusion'}, {'measure': 'Incidence of Adverse Events and Safety Outcomes', 'timeFrame': 'through study completion, an average of 30 days', 'description': 'The safety of adjunctive methylprednisolone therapy will be monitored to identify adverse events associated with corticosteroid use and complications in critically ill patients. This includes monitoring for hyperglycemia resulting in ketoacidosis, serious infections, gastrointestinal complications, and thromboembolic events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiogenic shock', 'heart failure cardiogenic shock', 'inflammation', 'corticosteroids'], 'conditions': ['Cardiogenic Shock', 'Heart Failure', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '41099686', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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/L 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", 'detailedDescription': 'Heart failure-related cardiogenic shock (HF-CS) is currently the most common form of shock in contemporary cardiac intensive care units. While temporary mechanical circulatory support (tMCS) devices effectively restore cardiac output and stabilize central hemodynamics, patient outcomes remain poor, with mortality approaching 40-50%. A major barrier to recovery in these patients is systemic inflammation and immune dysregulation. This creates a state of "hemodynamic dissonance," where central hemodynamics are restored but peripheral circulatory failure and end-organ dysfunction persist. This condition is further exacerbated by critical illness-related corticosteroid insufficiency (CIRCI), present in up to 50% of cardiogenic shock patients, as well as the inflammatory response triggered by the extracorporeal circuits themselves.\n\nThe CORTISHOCK-P trial is a prospective, randomized, open-label pilot study designed to test whether a short course of intravenous corticosteroids can effectively attenuate this systemic inflammatory storm. By specifically targeting patients with an inflammation-enriched phenotype (high-sensitivity C-reactive protein \\[hsCRP\\] ≥ 20 mg/L), this study introduces a biologically targeted pharmacological adjunct to complement tMCS and standard of care (SoC).\n\nThe study will enroll 30 adult patients admitted to the intensive care units at Brigham and Women\'s Hospital and Massachusetts General Hospital. Eligible patients will have SCAI Stage B or C HF-CS and a left ventricular ejection fraction of \\<40%. Following informed consent, participants will be randomized in a 1:1 ratio within 24 hours of admission to receive either standard of care alone or standard of care plus intravenous methylprednisolone. 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. Methylprednisolone was selected for its potent anti-inflammatory properties and lower mineralocorticoid activity, minimizing fluid retention while maximizing inflammatory suppression.\n\nThe primary objective is to evaluate the anti-inflammatory effects of the intervention, measured by the change in hsCRP concentrations from baseline to Day 7.\n\nSecondary objectives focus on clinical trajectories and resource utilization, including:\n\nCharacterizing the impact of corticosteroids on circulatory support requirements, including vasoactive inotropic score (VIS) trends, as well as the escalation and weaning of tMCS devices.\n\nDetermining the effects on organ dysfunction, specifically evaluating renal and hepatic dysfunction, as well as hemolysis indices.\n\nAssessing the overall feasibility, protocol adherence, and safety of administering corticosteroid therapy in this critically ill population.\n\nSafety will be continuously monitored, with specific attention given to adverse events such as hyperglycemia with ketoacidosis, new severe infections, gastrointestinal bleeding, and thromboembolic events. Clinical and laboratory assessments will be conducted daily from randomization through Day 7 or ICU discharge, with remote follow-up at 30 days post-discharge. Given the small sample size, statistical analyses will primarily focus on estimating effect sizes and precision to establish proof-of-concept and lay the groundwork for a definitive multicenter trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<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.\n\nHypoperfusion defined by altered mental state, cold extremities, livedo reticularis, urine output \\<30 mL/h, or lactate ≥2 mmol/L.\n\nIf invasive hemodynamic monitoring is available, CI \\<2.2 L/min/m2.\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 \\<20% from baseline, or tachycardia) without hypoperfusion (normal lactate).\n\nFor SCAI Stage B, hypotension SBP \\<90 mmHg or MAP \\<60 mmHg or \\> 30 mmHg drop from baseline, or tachycardia heart rate ≥100 bpm.\n\nFor SCAI Stage C, requiring only one vasoactive/inotrope and/or IABP from admission with CS until randomization, AND Vasoactive-inotropic score (VIS) \\<40.\n\nFor 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.\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/L and increase ≥ 100% from baseline lactate ≥ 2mmol/L or worst lactate ≥5mmol/L.\n\nDocumented history of chronic heart failure with reduced ejection fraction (LVEF \\<40%).\n\nEtiology of cardiogenic shock must be congestive heart failure decompensation (HF-CS).\n\nhsCRP ≥20 mg/L, 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/dL despite insulin therapy.\n\nOngoing uncontrollable infection, suspected concomitant sepsis, or mixed septic-cardiogenic shock.\n\nIschemic hepatitis or ALT \\>500 IU/L due to causes other than suspected hypoperfusion.\n\nSevere 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.\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/L, pH \\<7.2, 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).'}, 'identificationModule': {'nctId': 'NCT07461961', 'acronym': 'CORTISHOCK-P', 'briefTitle': 'CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'CORTISHOCK-P: A Randomized Pilot Trial of Corticosteroids as a Pharmacologic Adjunct to Temporary Mechanical Circulatory Support in Inflammation-Enriched Heart Failure Cardiogenic Shock', 'orgStudyIdInfo': {'id': '2025P002774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylprednisolone plus Standard of Care', 'description': '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', 'interventionNames': ['Drug: Methylprednisone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (Control)', 'description': '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', 'interventionNames': ['Other: Standard of Care (SOC)']}], 'interventions': [{'name': 'Methylprednisone', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Methylprednisolone plus Standard of Care']}, {'name': 'Standard of Care (SOC)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Standard of Care (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02446', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Ameesh M Isath, MBBS', 'role': 'CONTACT', 'email': 'aisath@bwh.harvard.edu', 'phone': '617-525-7053'}], 'facility': "Brigham and women's hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Ameesh M Isath, MBBS', 'role': 'CONTACT', 'email': 'aisath@bwh.harvard.edu', 'phone': '617-525-7053'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There are no immediate plans to share or transfer study data or biospecimens to external collaborators. All information obtained for this protocol will remain within Mass General Brigham (MGB) for storage, analysis, and publication of aggregate findings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor of Medicine', 'investigatorFullName': 'Ameesh Isath', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}