[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiogenic-shock\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiogenic-shock":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,95,0,25,[9,45,67,87,117,151,175,213,247,267,289,314,343,376,396,427,461,487,507,529,550,571,609,630,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100603810","empagliflozins-microcirculatory-effects-in-cardiogenic-shock-an-ancillary-pilot-study-of-the-empashock-trial-100603810",false,"NCT07141355","Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial","Microcirculatory Effects of Empagliflozin in Patients With Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial","EMPAmicroSHOCK","Inclusion Criteria:\n\n* Patient included in the main EMPASHOCK study\n* Patient has signed a consent form for the ancillary study\n* Patient is over 18 years old\n* Hospitalized in the Intensive Care Unit for cardiogenic shock\\*\n* Has been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock\\*\\*\n* Patient has the ability to take tablets orally\n* Person is affiliated with or a beneficiary of a social security system\n\nExclusion Criteria:\n\n* • GFR \\\u003C 20 ml\u002Fmin\u002F1.73m²\n\n  * Chronic dialysis\n  * Patient on SGLT2 inhibitors prior to ICU admission\n  * Known allergy to SGLT2 inhibitors or any of their excipients (in particular, patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome).\n  * Patient on lithium\n  * Patient with type 1 diabetes\n  * Patient in shock due to another cause or moribund patient (IGS 2 \\> 90)\n  * Cardiogenic shock cases excluded in the EMPASHOCK study: a. Heart transplant recipient or on a transplant list. b. Peripartum, adrenergic, valvular, restrictive, or post-embolic cardiomyopathy. c. Related to cardiotropic drug intoxication. d. Secondary to cardiac arrest where the patient remains comatose before inclusion.\n  * Woman of childbearing age without effective contraception\n  * Person referred to in Articles 10, 31, 32, 33, and 34 of EU Regulation 536\u002F2014, specifically:\n* Pregnant woman, woman in labor, or breastfeeding mother\n* Minor person (not emancipated)\n* Adult person subject to a legal protection measure (guardianship, curatorship, legal safeguard)","ALL","18 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","Despite advancements in treatment, the mortality rate for cardiogenic shock (CS) remains high at around 50%. The EMPULSE-HF trial showed that early introduction of empagliflozin in stabilized patients with acute heart failure led to a composite benefit in mortality, rehospitalization, and quality of life.\n\nGrowing evidence suggests that cardiogenic shock isn't just a problem of systemic macrocirculation (blood pressure, cardiac output). It also involves significant abnormalities in the systemic microcirculation. In fact, these microcirculatory parameters have proven to be better predictors of patient outcomes than traditional macrocirculatory measures.\n\nGiven its known vasculo-protective effects on the endothelium, empagliflozin may have a beneficial impact on the microcirculation, potentially explaining its positive effects in cardiogenic shock.\n\nThis study will explore this hypothesis by analyzing the microcirculation in real-time using the CytoCam-IDF imaging videomicroscope and its MicroTools software. The goal is to gain a deeper understanding of how empagliflozin affects the microcirculation during cardiogenic shock.",[28],"Cardiogenic Shock",[28,30,31],"Acute Heart failure","Heart failure","RECRUITING","2026-08-18",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":36},"2025-12-12",{"date":40,"type":22},"2027-09-30",{"name":42,"class":43},"University Hospital, Strasbourg, France","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":49,"conditions":54,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100652494","prognostic-value-enhancement-of-sequential-organ-failure-assessment-sofa-score-by-neutrophil-lymphocyte-ratio-and-red-cell-distribution-width-in-cardiogenic-shock-patients-100652494","NCT07773597","Prognostic Value Enhancement Of Sequential Organ Failure Assessment )SOFA( Score by Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n\nDiagnosis of cardiogenic shock based on:\n\nSystolic blood pressure \\\u003C 90 mmHg for ≥30 minutes or need for vasopressor support Signs of tissue hypoperfusion (cold extremities, oliguria, altered mental status, elevated lactate) Evidence of cardiac dysfunction Cardiogenic shock secondary to acute coronary syndrome or other cardiac causes Availability of complete blood count on admission\n\nExclusion Criteria:\n\n* Septic, hypovolemic, or obstructive shock Active infection or chronic inflammatory disease Hematological disorders affecting leukocytes or red blood cells Malignancy Chronic liver disease Recent blood transfusion Patients on immunosuppressive or steroid therapy",{"count":52,"type":22},150,"OBSERVATIONAL",[28],[56],"Neutrophil-Lymphocyte Ratio and Red Cell Distribution Width in Cardiogenic Shock Patients.","NOT_YET_RECRUITING","2026-08-14",{"date":60,"type":36},"2026-08-19",{"date":62,"type":22},"2026-08-30",{"date":64,"type":22},"2027-01-31",{"name":66,"class":43},"Sohag University",{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":44},"100652283","safety-and-efficacy-of-the-extracorporeal-ventricular-assist-system-in-car-diogenic-shock-a-prospective-multicenter--single-arm-study-100652283","NCT07769528","Safety and Efficacy of the Extracorporeal Ventricular Assist System in Car Diogenic Shock: A Prospective, Multicenter , Single-Arm Study","Inclusion Criteria:(1) The subject voluntarily participates in the study and has signed the informed consent form; (2) Age ≥ 18 years; (3) Subjects diagnosed with cardiogenic shock or low cardiac output syndrome meeting one of the following clinical scenarios: Unstable circulation secondary to low cardiac output after cardiac surgery, or inability to wean from cardiopulmonary bypass during surgery; Acute decompensation of heart failure (including ischemic cardiomyopathy, dilated cardiomyopathy, etc.) with persistent hemodynamic instability despite conventional pharmacotherapy and IABP support; Hemodynamic instability in patients with end-stage heart failure prior to heart transplantation or transition to other long-term therapeutic strategies.\n\n(4) Cardiogenic shock shall meet the following criteria:\n\nSigns of inadequate perfusion (at least one item):\n\n① Altered mental status unexplainable by other causes: agitation in the early stage, lethargy and stupor in the late stage;\n\n* Cool, clammy and mottled skin of extremities; ③ Oliguria (\\\u003C30 mL\u002Fh or 0.5 mL\u002Fkg\u002Fh).\n\nHypotension with adequate intravascular volume (at least one item):\n\n* Systolic blood pressure ≤90 mmHg or mean arterial pressure ≤60 mmHg lasting more than 30 minutes; ② Requirement for vasoactive agents or inotropic agents to maintain systolic blood pressure ≥90 mmHg; ③ Systolic blood pressure ≥90 mmHg after excluding trauma, intoxication, hypoxia and other factors, accompanied by obvious manifestations of hypoperfusion.\n\nLaboratory or hemodynamic findings (at least one item):\n\n* Hemodynamics: Cardiac Index (CI) ≤2.2 L\u002Fmin·m², Pulmonary Capillary Wedge Pressure (PCWP) ≥15 mmHg;\n\n  * Laboratory test: Lactate ≥2 mmol\u002FL; ③ Serum creatinine increased to 1.5 times the baseline value, or glomerular filtration rate decreased by \\>50%; ④ ALT elevated to 3 times the upper limit of normal. (5) Authorized clinicians confirm that all feasible measures have been implemented to correct abnormalities of arterial blood gas, electrolyte disorders, hypovolemia, hypervolemia, bradycardia, arrhythmia and incomplete rewarming.\n\nExclusion Criteria:\n\n* (1) Patients who fail to comply with medical treatment protocols; (2) Patients with established irreversible central nervous system injury; (3) Patients intolerant to anticoagulants (such as heparin or equivalent alternatives); (4) Patients with severe infection, malignant tumor, or end-stage multiple organ failure; (5) Patients with implanted mechanical heart valves, moderate to severe aortic regurgitation, or unrepaired structural cardiac lesions (e.g., ventricular septal rupture); (6) Patients with severe peripheral vascular disease or irreversible neurological\u002Fneuromuscular disorders; (7) Patients with pulmonary embolism, pulmonary infarction, or uncorrectable pulmonary hypertension; (8) Patients with psychiatric disorders requiring long-term standardized treatment or relevant medical history, drug abusers, and patients positive for HIV or syphilis; (9) Patients with a history of stroke or transient ischemic attack (TIA) within the past 3 months; (10) Patients with active bleeding or disorders of coagulation; (11) Female patients during pregnancy; (12) Patients who have participated in another clinical trial within 1 month, or are currently participating in another clinical trial that has not reached its endpoint; (13) Patients with other conditions deemed ineligible for this trial by the investigator.",{"count":74,"type":22},40,[25],"Study Title: Safety and Efficacy of Extracorporeal Ventricular Assist System for Cardiogenic Shock: A Prospective, Multicenter, Single-Arm Clinical Study Objective: To evaluate the safety and efficacy of temporary mechanical circulatory support and bridge therapy with an extracorporeal ventricular assist system in patients with cardiogenic shock or weaning failure from cardiopulmonary bypass, and to comprehensively assess the device, pump head, cannulae and tubing.\n\nPilot Phase: Clinical validation of Class III medical device. Study Design: Prospective, multicenter, single-arm target-value design. Sample Size: 40 patients. Primary Endpoint: Success rate of mechanical circulatory support.\n\nSecondary Endpoints:\n\n30-day survival after transition to long-term therapy (VAD\u002Ftransplant); 30-day cardiovascular mortality after device explantation; MACCE incidence; Mean support duration; Incidence of bleeding, thrombosis, hematologic events, acute renal\u002Fhepatic dysfunction, infection; Hemodynamic trends during support; Changes in SCr, BUN, ALT, TBIL at use, discharge and 30 days post-explantation vs baseline; Device satisfaction. Follow-up: Within 6 hours of initiation, during support, 24 hours, 7 days, 30 days post-explantation\u002Ftransition, and at discharge.\n\nAll clinical data were collected, managed and analyzed by an independent data and statistical center and clinical monitoring unit to support safety\u002Fefficacy evaluation and market approval.",[28],"2026-08-13",{"date":33,"type":36},{"date":81,"type":36},"2026-03-23",{"date":83,"type":22},"2028-12-31",{"name":85,"class":86},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":44},"100628463","phase-2-cortishock-p-trial-of-corticosteroids-in-inflammation-enriched-heart-failure-cardiogenic-shock-100628463","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).","80 Years",{"count":97,"type":22},30,[99],"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",[28,102,103],"Heart Failure","Inflammation",[105,106,107,108],"cardiogenic shock","heart failure cardiogenic shock","inflammation","corticosteroids","2026-08-11",{"date":78,"type":36},{"date":112,"type":22},"2026-10-01",{"date":114,"type":22},"2029-02-01",{"name":116,"class":43},"Brigham and Women's Hospital",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":44},"100651657","routine-microaxial-heart-pump-support-and-protocolized-pulmonary-artery-catheter-monitoring-versus-standard-care-in-heart-attack-related-cardiogenic-shock-100651657","NCT07762560","Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock","Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock","DOUBLE-SHOCK","Inclusion Criteria:\n\nCardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:\n\n1. Planned immediate angiography and revascularization (preferred PCI)\n2. Systolic blood pressure \\\u003C100 mmHg or catecholamines required to maintain pressure \\>90 mmHg during systole\n3. Arterial lactate \\>2.0 mmol\u002FL\n4. Echocardiogram with LVEF \\\u003C40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm\n\nExclusion Criteria:\n\n1. Age \\\u003C18 and \\>80 years\n2. Shock duration \\>12 hours\n3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).\n4. Shock due to mechanical complication of AMI\n5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression \\>10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression \\\u003C10 min are also eligible)\n6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion\n7. Any unwitnessed OHCA\n8. Refractory cardiac arrest with ongoing chest compression\n9. Evidence of severe right ventricular failure\n10. Severe aorta valve regurgitation\u002Fstenosis\n11. Severe peripheral arterial obstructive disease precluding mAFP placement\n12. Abnormalities of the aorta precluding mAFP device placement\n13. Presence of a mechanical aortic valve prosthesis\n14. Left ventricular thrombus\n15. Infective endocarditis\n16. Life expectancy \\\u003C1 year due to comorbidities\n17. Mental disorder or language barrier that preclude informed consent\n18. Known pregnancy",{"count":126,"type":22},780,[25],"The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).\n\nThe main questions it aims to answer are:\n\n* Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?\n* Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?\n\nResearchers will compare four treatment combinations to see if mechanical circulatory support and\u002For advanced hemodynamic monitoring reduce mortality in AMI-CS patients:\n\n* Microaxial flow pump + pulmonary artery catheter\n* Microaxial flow pump + conventional monitoring\n* Medical therapy alone + pulmonary artery catheter\n* Medical therapy alone + conventional monitoring\n\nParticipants will:\n\n* Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups\n* Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI\n* Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring\n* Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years",[28,130,131],"Acute Myocardial Infarction (AMI)","Heart Failure, Acute",[133,134,135,136,137,138,139,140,141,142,143],"2x2 factorial design","Mortality","Intensive care","Percutaneous coronary intervention","Hemodynamic monitoring","Mechanical circulatory support","Impella","Microaxial flow pump","AMI-CS","Acute myocardial infarction","Cardiogenic shock","2026-08-07",{"date":78,"type":36},{"date":112,"type":22},{"date":148,"type":22},"2037-04",{"name":150,"class":43},"Leipzig Heart Science gGmbH",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":44},"100651251","phase-4-capital-offload-shock-100651251","NCT07756801","CAPITAL OFFLOAD-SHOCK","Optimal Timing of Renal Replacement Therapy in Hypervolemic Cardiogenic Shock","OFFLOAD-SHOCK","Inclusion Criteria:\n\n* adult patients \\>\u002F= 18 years of age admitted to an intensive care unit\n* Diagnosed clinically with Society for Cardiovascular Angiography and Interventions (SCAI) Class C or D cardiogenic shock\n* Clinical or hemodynamic evidence of volume overload\n\nExclusion Criteria:\n\n* Patients whose care plan, as determined by the treating clinical team, will not include renal replacement therapy\n* Decision has already been made by the treating clinical team to initiate renal replacement therapy\n* Hyperkalemia with serum potassium \\>\u002F= 6mmol\u002FL at the time of screening\n* Severe metabolic acidosis with serum bicarbonate \\\u003C\u002F= 12 mmol\u002FL at the time of screening\n* Severe azotemia with serum urea \\>\u002F= 40 mmol\u002FL at the time of screening\n* Acute intoxication necessitating use of renal replacement therapy\n* Recent renal replacement therapy (within 30 days)\n* Known end-stage renal disease (defined as an estimated glomerular filtration rate \\\u003C15 ml\u002Fmin\u002F1.73m2\n* presentation with out-of-hospital cardiac arrest",{"count":160,"type":22},456,[162],"PHASE4","CAPITAL OFFLOAD-SHOCK will aim to answer if early use of renal replacement therapy, like dialysis, in patients with reduced body fluids causing the heart to be unable to pump enough blood through the body reduces in-hospital death when compared to the current standard of care. The current standard of care is to wait until renal replacement therapy is clinically necessary.",[165,28,166],"Hypervolemia","Renal Replacement Therapy","2026-08-06",{"date":109,"type":36},{"date":170,"type":22},"2026-09-01",{"date":172,"type":22},"2031-09",{"name":174,"class":43},"Ottawa Heart Institute Research Corporation",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":193,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":44},"100641181","compare-vent-feasibility-pilot-study-100641181","NCT07656259","COMPARE-VENT Feasibility Pilot Study","COMPARE-VENT Feasibility Pilot Study: A Pragmatic Cluster Randomized Crossover Trial for Ventilation Strategies and Hemodynamic Impact in Critically Ill Patients With Cardiovascular Disease","Inclusion Criteria:\n\nEligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration \\>12 hours.\n\nPre-Specified Subgroups for exploratory outcomes:\n\n1. SCAI Stages C-E Cardiogenic Shock\n2. Mechanical circulatory support use, including intra-aortic balloon pumps and microaxial flow pumps, including Impella CP, RP Impella Flex, and Impella 5.5 devices\n3. Heart failure with reduced ejection fraction: LVEF \\\u003C40% or;\n4. Moderate to severe RV systolic dysfunction or;\n5. Moderate to severe Pulmonary hypertension, as defined by ACC\u002FAHA\u002FESC guidelines\n\nExclusion Criteria:\n\n1. Expected duration of intubation \\\u003C12 hours.\n2. Severe COPD, bronchopleural fistulas, or severe ARDS (Berlin criteria P\u002FF \\\u003C100, in the absence of pulmonary edema)\n3. Home ventilator or chronic tracheostomy.\n4. Pregnant, incarcerated, patients or those receiving extracorporeal membrane oxygenation",{"count":183,"type":22},75,[25],"Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20% patients requiring invasive mechanical ventilation (IMV). IMV among patients with impaired cardiovascular reserve is further compounded by the adverse impact of positive pressure ventilation (PPV) and systemic sedation on intracardiac hemodynamics, pulmonary vascular mechanics and consequently end-organ perfusion. Despite widespread use, evidence guiding optimal ventilatory practices and mode selection in cardiovascular intensive care unit patients remains limited. Pressure-controlled and volume-controlled ventilation may differ in their effects on patient-ventilator synchrony, sedation requirements, and hemodynamic impact, but comparative data among patients with critical cardiac disease remains inconclusive. This pilot study will evaluate the feasibility of implementing a pragmatic cluster-randomized crossover trial comparing ventilatory modes in a contemporary cardiovascular intensive care unit.",[187,188,189,190,191,28,192],"Respiration Failure","Cardio Vascular Disease","Cardiogenic Pulmonary Oedema","Critical Illness","Mechanical Ventilation","Cardiopulmonary",[194,195,143,196,197,198,199,200,201,202,203],"Cardiovascular disease","Cardiac arrest","Respiratory failure","Cardiopulmonary interactions","Critical illness","Intensive care unit","Critical care therapies","Outcomes","Mechanical ventilation","Positive pressure ventilation","2026-08-05",{"date":206,"type":36},"2026-08-10",{"date":208,"type":36},"2026-07-01",{"date":210,"type":22},"2027-06-30",{"name":212,"class":43},"Mayo Clinic",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":230,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100522242","multicenter-trial-of-ecmo-in-children-with-severe-cardiac-failure-using-the-cardiohelp-system-100522242","NCT06080074","Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System","Multicenter Trial to Evaluate the Safety and Effectiveness of the Cardiohelp System for up to 30 Days of Support in Children With Severe Cardiac Failure","TROLLEY","Inclusion Criteria:\n\n1. Age 0 to 16 years of age (i.e., \\\u003C17 years)\n2. Body weight 2.5 to 80 kilograms\n3. VA-ECMO use for primary cardiac failure using the Cardiohelp system.\n4. First ECMO run during the current hospitalization\n5. Written informed consent from the parent or legally appointed representative (LAR)\n\nExclusion Criteria:Children must not meet any of the following exclusion criteria after ECMO cannulation and immediately prior to consent:\n\n1. Gestationally-corrected age \\\u003C37 weeks\n2. Bleeding or coagulopathy that is a contraindication to anticoagulation\n3. Irreversible renal, hepatic or lung failure\n4. Stroke or uncertain neurological status within the past 30 days\n5. Severely malnourished\n6. Use of an ECMO system other than the Cardiohelp\n7. VV-ECMO or ECMO for primary respiratory failure\n8. Goals of patient to focus on comfort measures only.\n9. Failure to separate from cardiopulmonary bypass\n10. Allergy or contraindication to receiving UFH or bivalirudin as a primary anticoagulant on ECMO.\n11. Patients who are pregnant or breastfeeding.\n12. Unable to undergo randomization within 30 hours following ECMO cannulation (randomized cohort only)","0 Years","16 Years",{"count":224,"type":22},50,[99],"There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to:\n\n1. To evaluate the safety and effectiveness of the Cardiohelp Device for VA-ECMO (heart-lung support) for up to 30 days of support in children with severe heart failure with the goal to support its FDA clearance in children.\n2. To evaluate heparin versus bivalirudin as the primary blood thinner (anticoagulant) in a randomized trial of children supported with the Cardiohelp ECMO System with the goal to plan a phase III (pivotal) randomized clinical trial\n\nThe main questions the Cardiohelp single-arm trial seeks to answer are:\n\n* What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO?\n* Should the Cardiohelp device be FDA-cleared for children based on the results of the study?\n* What are the optimal performance specifications of the Cardiohelp device in children?\n\nThe main questions the blood thinner randomized trial seeks to answer are:\n\n* Which blood thinner is more promising (i.e., more effective and safer) in children on the Cardiohelp device?\n* How should a pivotal trial of heparin vs. bivalirudin be designed so it is the most informative and efficient to determine the best blood thinner?\n\nChildren who are receiving the Cardiohelp device will be approached and consented to participate if interested. For the Cardiohelp device trial, participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. For the blood thinner randomized trial, participants will be randomized 1:1 to blood thinner strategy to determine which blood thinner has the fewest bleeding and clotting complications.\n\nFor the Cardiohelp single-arm trial, participant outcomes will be compared to performance goals (PG) derived from the ECMO literature. For the blood thinner randomized trial, the amount of bleeding and clotting will be measured.\n\nThe study is funded by an R01 grant from the FDA's Office of Orphan Product Development (OOPD).",[102,28,228,229],"Congenital Heart Disease","Cardiomyopathies",[231,232,233,234,235,236,237,238],"blood thinner","ECMO","heart failure","bivalirudin","heparin","FDA regulation","pediatric medical devices","510k clearance",{"date":206,"type":36},{"date":241,"type":36},"2025-04-15",{"date":243,"type":22},"2029-09",{"name":245,"class":43},"Stanford University",5,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":44},"100493089","early-phase-1-cardiac-power-output-in-cardiogenic-shock-patients-100493089","NCT05700617","Cardiac Power Output in Cardiogenic Shock Patients","Myocardial Reserve in Advanced Heart Failure Patients","Inclusion Criteria:\n\n1. LVEF ≤ 40%\n2. Referred for RHC for:\n\n   1. Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR\n   2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR\n   3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR\n   4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI\n3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml\u002Fmin\u002F1.73 m2\n4. Age ≥ 18 years-old\n5. Intent for admission based on RHC data\n\nExclusion Criteria:\n\n1. eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n2. Severe, non-revascularized coronary artery disease\n3. Concurrent acute coronary syndrome\n4. Age \\\u003C 18 years-old\n5. History of significant ventricular arrhythmia without an ICD",{"count":246,"type":22},[256],"EARLY_PHASE1","The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.",[102,28],"2026-08-04",{"date":167,"type":36},{"date":262,"type":36},"2023-07-06",{"date":264,"type":22},"2027-12",{"name":266,"class":43},"University of Chicago",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100632578","multimodal-phenotyping-in-patients-referred-with-acute-cardiac-failure-100632578","NCT07515508","Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE","MIRACLE","Inclusion Criteria:\n\n* Patients hospitalized with acute heart failure SCAI stage B - E.\n\nExclusion Criteria:\n\n* Not capable of providing informed consent due to reasons not attributable to cardiogenic shock\n* Cardiogenic shock following cardiothoracic surgery",{"count":275,"type":22},600,"The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. The main question is whether clinical findings, imaging results, and biomarkers, including sex-specific factors, are associated with the risk of death within 30 days. Participants will not receive an experimental treatment. Researchers will collect data from routine care, collect additional blood and urine samples for biobanking, and follow participants after hospital discharge",[28,278],"Acute Heart Failure (AHF)","2026-07-28",{"date":281,"type":36},"2026-07-29",{"date":283,"type":36},"2024-08-07",{"date":285,"type":22},"2028-07-31",{"name":287,"class":43},"University Heart Center Freiburg - Bad Krozingen",4,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":296,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":313},"100615539","magenta-elevate-clinical-feasibility-study-in-cardiogenic-shock-100615539","NCT07293923","Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock","Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock","Inclusion Criteria:\n\n* Cardiogenic shock of less than 24 hours duration.\n* Left ventricular ejection fraction \\\u003C 45% and \\> 15%, as determined by echocardiography on the day of inclusion.\n* No more than mild right ventricular dysfunction, as determined by echocardiography on the day of inclusion.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis.\n* Patient with oxygen saturation \\\u003C 90% (pulse oximeter\u002Farterial) at the planned time of device placement (uncorrected by oxygen supplementation or intubation).\n* Sustained VT (at the time of the enrollment).\n* Significant right heart failure\u002Fright ventricular dysfunction.\n* Awake patient who is unable to remain in a stable recumbent position due to restlessness or lack of cooperation for other reasons.\n* Hypertrophic obstructive cardiomyopathy.\n* Left ventricular thrombus.\n* Subjects with a placed IABP.\n* Mitral and\u002For aortic valve prothesis, or more than mild native mitral or aortic valve stenosis.\n* Aortic valve insufficiency ≥ 2+ (on a 4-grade scale).\n* Mechanical complication of myocardial infarction (e.g., ventricular septal rupture, papillary muscle rupture) or evidence of uncorrected Ventricular Septal Defect or Atrial Septal Defect (VSD\u002FASD).\n* Brain damage (e.g., anoxic) or suspected brain damage.\n* Stroke or transient ischemic attack within the past 3 months.\n* Uncorrectable abnormal coagulation parameters (defined as platelet count \\\u003C 100,000 or INR \\> 2.0 or fibrinogen \\\u003C 1.5 g\u002FL) or active uncontrolled bleeding.\n* Allergy, sensitivity or intolerance to heparin, aspirin, Adenosine Diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia.\n* Known allergy, sensitivity or intolerance to nickel.\n* Known or suspected severe lung disease.\n* Evidence of any vascular disease that would preclude placement of the device (e.g., severely calcified and stenosed ilio-femoral vessels).\n* Aortic pathology, such as aortic aneurysms, extreme tortuosity, or calcifications that could pose an undue additional risk to the placement of a pLVAD device.\n* Any known or suspected disorder causing fragility of blood cells or hemolysis.\n* Subject participation in another investigational drug or device trial (post-market registries may be approved by Magenta Medical).\n* Life expectancy \\\u003C 1 year due to comorbidities.","40 Years","89 Years",{"count":299,"type":22},10,[25],"The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left ventricular failure.",[28,102,130],"2026-07-15",{"date":305,"type":36},"2026-07-16",{"date":307,"type":36},"2025-11-05",{"date":309,"type":22},"2028-02-28",{"name":311,"class":312},"Magenta Medical Ltd.","INDUSTRY",8,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":322,"targetDuration":4,"studyType":23,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":44},"100646673","crp-apheresis-in-infarct-related-cardiogenic-shock-100646673","NCT07687017","CRP Apheresis in Infarct-Related Cardiogenic Shock","Selective C-Reactive Protein Apheresis in Cardiogenic Shock Complicating Acute Myocardial Infarction (CRP-SHOCK Trial)","CRP-SHOCK","Inclusion Criteria:\n\n* Cardiogenic shock complicating acute myocardial infarction with planned revascularization by percutaneous coronary intervention (PCI).\n* Cardiogenic shock defined as:\n* Systolic blood pressure \\\u003C90 mmHg for \\>30 minutes or requirement of catecholamine infusion to maintain systolic blood pressure ≥90 mmHg, and\n* Signs of impaired organ perfusion (at least one of the following): Cold, clammy skin and extremities, Altered mental status, Oliguria with urine output \\\u003C30 mL\u002Fhour, Arterial lactate \\>2 mmol\u002FL\n* C-reactive protein (CRP) level ≥7 mg\u002FL at baseline.\n* Age ≥18 years.\n* Informed consent provided by the participant or, if the participant is unable to consent, inclusion after assessment and documentation of the presumed patient's will by two physicians (one independent), with informed consent obtained as soon as possible.\n\nExclusion Criteria:\n\n* Fever (body temperature \\>38°C) or acute infection with fever within the last 14 days.\n* Chronic inflammatory disease.\n* Known history of severe hepatic failure.\n* Chronic kidney disease with creatinine clearance \\\u003C30 mL\u002Fmin\u002F1.73 m² prior to hospital admission.\n* Life expectancy \\\u003C12 months prior to cardiogenic shock.\n* Participation in another interventional clinical trial.\n* Pregnancy.\n* Resuscitation duration \\>30 minutes.\n* Cardiogenic shock due to causes other than acute myocardial infarction.\n* Onset of cardiogenic shock \\>12 hours before randomization.\n* Age \\>80 years.",{"count":224,"type":22},[25],"Cardiogenic shock complicating acute myocardial infarction remains associated with high short-term mortality despite guideline-directed therapy. Systemic inflammation, particularly elevated C-reactive protein (CRP), may contribute to ongoing myocardial injury and organ dysfunction.\n\nThe CRP-SHOCK trial is an investigator-initiated, prospective, randomized, open-label, multicenter pilot study evaluating selective CRP apheresis as an adjunct to standard of care in patients with infarct-related cardiogenic shock. Patients are randomized to receive either standard therapy alone or standard therapy plus selective CRP apheresis using the PentraSorb®-CRP system.\n\nThe primary objective is to assess the effect of CRP apheresis on the CLIP score at 66 ± 8 hours after randomization. Secondary objectives include clinical outcomes, inflammatory biomarkers, and safety endpoints.",[28,130],[327,328,329,103,330,142,331,332,333,334],"C-reactive protein","CRP apheresis","Selective CRP apheresis","Infarct-related cardiogenic shock","CLIP score","PentraSorb-CRP","Pilot study","Multicenter study","2026-07-03",{"date":337,"type":36},"2026-07-07",{"date":339,"type":22},"2026-07-20",{"date":341,"type":22},"2027-10-31",{"name":150,"class":43},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":355,"conditions":356,"keywords":361,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":44},"100492965","phase-1-individualized-or-conventional-transfusion-strategies-during-peripheral-va-ecmo-100492965","NCT05699005","Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO","Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE","ICONE","Inclusion Criteria:\n\n* Age of 18 and older,\n* supported by peripheral VA-ECMO\n* for cardiogenic shock\n* Life expentency \\>90 days\n* Central venous line available ScVO2 measurement\n\nExclusion Criteria:\n\n* Pregnancy,\n* Lack of health insurance,\n* Opposition to blood transfusion,\n* Known congenital hemoglobin disease or disorder,\n* Metabolic alcaloosis with pH\\>7.8,\n* eCPR,\n* Legally incapacitated adults",{"count":352,"type":22},236,[354],"PHASE1","This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.\n\nAn individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness",[28,357,358,359,360],"Extracorporeal Membrane Oxygenation","Transfusion Related Complication","Anemia","Oxygen Delivery",[232,362,363,364,365,366],"ECLS","Refractory cardiogenic shock","Transfusion","ScVO2","Outcome","2026-06-30",{"date":369,"type":36},"2026-07-02",{"date":371,"type":36},"2023-09-18",{"date":373,"type":22},"2028-12-18",{"name":375,"class":43},"University Hospital, Lille",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":383,"targetDuration":385,"studyType":53,"phases":4,"briefSummary":381,"conditions":386,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":288},"100539762","abiomed-impella-rt-daq---observational-study-100539762","NCT06308055","Abiomed Impella RT-DAQ - Observational Study","Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition","Inclusion Criteria:\n\n1. Ongoing or planned intensive care management with Impella support\n2. Presence or planned placement of a cardiac output measurement\n\n   1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)\n   2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Pregnancy\n3. Anticipated support duration \\\u003C24 h",{"count":384,"type":22},125,"2 Days",[28],"2026-06-16",{"date":389,"type":36},"2026-06-17",{"date":391,"type":36},"2024-10-04",{"date":393,"type":22},"2027-12-31",{"name":395,"class":312},"Abiomed Inc.",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":406,"conditions":407,"keywords":410,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":44},"100642943","cardiovascular-outcomes-registry-in-cardiogenic-shock-cor-shock-100642943","NCT07597291","Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK)","Cardiovascular Outcomes Registry in Cardiogenic SHOCK","COR-SHOCK","Inclusion Criteria:\n\n-Cardiogenic shock according to the following criteria:\n\nCardiac disorder resulting in hypotension, defined as at least one of the following:\n\n* Systolic blood pressure (SBP) \\\u003C90 mmHg for ≥30 minutes, or\n* Requirement for vasopressors, inotropes, or mechanical circulatory support to maintain SBP ≥90 mmHg\n\nAND\n\nEvidence of tissue hypoperfusion, defined by the presence of at least one of the following:\n\n* Serum lactate \\>2 mmol\u002FL\n* Acute kidney injury and\u002For oliguria\n* Acute hepatic injury\n* Cool or mottled extremities\n* Altered mental status\n\nAND\n\nClinical presentation judged to be primarily attributable to a cardiac etiology.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Other primary etiologies of shock at presentation (e.g., hypovolemic, hemorrhagic, septic, obstructive shock due to acute pulmonary embolism, or anaphylactic shock).\n* Refusal to participate in the study (applicable only to the prospective cohort).",{"count":405,"type":22},800,"The goal of this observational study is to evaluate the clinical outcomes and management approaches of cardiogenic shock throughout the years in adult patients admitted to a Cardiology Department. The main questions it aims to answer are:\n\n* How have management strategies and clinical outcomes for cardiogenic shock evolved over time?\n* How do clinical, laboratory, and advanced hemodynamic monitoring parameters relate to patient survival and overall prognosis in this population?\n\nResearchers will evaluate clinical data collected from 2017 onwards to see if therapeutic advancements and changes in clinical management over the years have led to improved patient survival and quality of care.\n\nParticipants will:\n\n* Receive standard, routine medical care for cardiogenic shock as determined by their clinical team (no experimental interventions will be introduced).\n* Have their clinical, laboratory, and imaging data collected from hospital electronic records during their stay.\n* Be followed for up to 1 year after hospital admission to evaluate long-term survival and clinical outcomes.",[408,28,409],"Cardiogenic Shock Acute","Cardiogenic Shock Post Myocardial Infarction",[28,411,412,413,414,415,416,417],"Shock, Cardiogenic","Hemodynamic Monitoring","Pulmonary Artery Catheterization","Swan-Ganz","Mechanical Circulatory Support","Prognosis","Myocardial Infarction","2026-06-09",{"date":420,"type":36},"2026-06-11",{"date":422,"type":36},"2026-06-10",{"date":424,"type":22},"2036-12-31",{"name":426,"class":43},"Hospital de Santa Cruz, Portugal",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":437,"studyType":53,"phases":4,"briefSummary":438,"conditions":439,"keywords":446,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":44},"100643069","beat-shock-registry-100643069","NCT07643610","BEAT-SHOCK Registry","BEAT-SHOCK (Basel Evaluation of Acute Therapy in Cardiogenic SHOCK) Registry","BEAT-SHOCK","* Patients admitted with cardiogenic shock to the University hospital Basel (diagnosis at the time of admission) or development of cardiogenic shock during the hospital stay\n* Age ≥18 years\n* Provision of written ICF\n* Clinical diagnosis of cardiogenic shock.\n* impaired organ perfusion due to primary cardiac dysfunction,\n* persistent systolic blood pressure (SBP) \\\u003C90 mmHg for ≥30 minutes, or the need for vasopressors, inotropes, or mechanical circulatory support (MCS) to maintain adequate perfusion and\n* evidence of systemic hypoperfusion with arterial lactate ≥2 mmol\u002FL or venous lactate ≥3 mmol\u002Fl and ≥1 of the following:\n* Cold or clammy extremities\n* Altered mental status\n* Reduced urine output\n* Signs of volume overload or congestion (on clinical exam, imaging, or invasive monitoring)\n* Patients with normotensive cardiogenic shock (SBP ≥90 mmHg without vasopressors or MCS) may also be included if clear signs of hypoperfusion (arterial lactate ≥2 mmol\u002FL or venous lactate ≥3 mmol\u002Fl) and cardiac dysfunction are present and alternative causes are excluded\n\nExclusion criteria:\n\n* Age \\\u003C18 years\n* Refusal to provide informed consent by the patient or their legally authorized representative",{"count":436,"type":22},8000,"5 Years","This regulation defines the purpose, the operational processes, and the organization of the registry BEAT-SHOCK (Basel Evaluation of Acute Therapy in cardiogenic SHOCK). It describes the requirements for collecting, storing, processing, managing and sharing health-related registry data.",[28,440,441,442,443,444,445],"Myocardial Infarction (MI)","Fulminant Myocarditis","Acute Decompensated Heart Failure","Severe Valvular Disease","Post-cardiotomy","Perioperative Cardiogenic Shock",[105,447,448,449,450,451,452],"Myocardial infarction (MI)","Fulminant myocarditis","Acute decompensated heart failure","Severe valvular disease","Post-cardiotomy or perioperative cardiogenic shock","wide range of cardiogenic shock etiologies","2026-06-08",{"date":420,"type":36},{"date":456,"type":36},"2025-10-01",{"date":458,"type":22},"2035-10-01",{"name":460,"class":43},"University Hospital, Basel, Switzerland",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":44},"100638835","optimize-55---optimizing-impella-55-outcomes-through-advanced-data-science-100638835","NCT07619144","OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science","Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study","OPTIMIZE","Inclusion Criteria:\n\n* Adult patients who were treated for cardiogenic shock and supported with an Impella 5.5 micro-axial flow pump\n* Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets\n\nExclusion Criteria:\n\n* Patients supported with an Impella 5.5 for indications other than cardiogenic shock (e.g., protected PCI or CABG)\n* Patients younger than 18 years\n* Patients with incomplete data, procedural records, or demographic information",{"count":470,"type":22},100,"The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and real-world clinical data of cardiogenic shock patients.\n\nTherefore, secondary objectives are essential to consolidating a retrospective longitudinal analysis of Impella 5.5 pump data alongside ICU digital health record datasets to:\n\n1. Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.\n2. Integrate pump data with ICU clinical data to identify patterns associated with therapy outcomes, including native heart recovery, heart replacement therapy, and mortality while on device support.\n3. Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.",[28,415,409],[105,474,475,476,477],"mechanical circulatory support","Impella 5.5","micro-axial flow pump","data science","2026-05-27",{"date":480,"type":36},"2026-06-01",{"date":482,"type":36},"2026-05-08",{"date":484,"type":22},"2029-05-30",{"name":486,"class":43},"Medical University of Vienna",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":4},"100638205","oxygen-delivery-index-odin-study-100638205","NCT07601828","Oxygen Delivery Index (ODIN) Study","A Single-Site, Pilot Study Using ODI Technology to Measure Microvascular Function and Oxygen Extraction in Patients With Advanced Heart Failure and Cardiogenic Shock","Inclusion Criteria:\n\n* 18 years or older\n* Diagnosed with advanced heart failure or cardiogenic shock\n* Patient already has a pulmonary artery catheter placed\n\nExclusion Criteria:\n\n* Inability to obtain consent from the patient (including patients who are intubated at time of consent)\n* Liver or kidney transplant patients\n* Patients on dialysis\n* Patients with ongoing chronic alcohol use disorder or substance abuse disorder\n* Patients on home assisted mechanical ventilation (via tracheotomy or noninvasive) or requiring home oxygen.\n* Patients with a recent cardiac arrest\n* Patients with severe neurologic injury or dysfunction.\n* Prisoners\n* Patients with decisional impairment\u002F cognitive decline.",{"count":97,"type":22},[25],"The objective of this study is to test the feasibility and efficacy of a novel, non-invasive electronic device to monitor the adequacy of tissue perfusion in patients with advanced heart failure or cardiogenic shock in the ICU.\n\nThis single-site pilot study will evaluate the FDA-approved Oxygen Delivery Index (ODIN), a non-invasive method for assessing microvascular function and oxygen extraction, in patients with advanced heart failure and cardiogenic shock. ODIN comprises ODI Technology (including CAM, DRS, a medical PC, and an enclosure), a standardized data acquisition procedure, and proprietary analysis software.\n\nThirty consecutive patients will be enrolled upon hospital presentation, undergoing ODIN measurement alongside standard clinical assessments.\n\nODI Tech data are collected solely for research correlation with established diagnostic standards; measurements will not be used to diagnose or contribute to any clinical decision making, and will not be used for any clinical indication or guidance.",[102,28],"2026-05-18",{"date":500,"type":36},"2026-05-22",{"date":502,"type":22},"2026-05",{"date":504,"type":22},"2028-05",{"name":506,"class":43},"NYU Langone Health",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":514,"targetDuration":516,"studyType":53,"phases":4,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":44},"100385172","altshock-2-registry-100385172","NCT04295252","Altshock-2 REGISTRY","Cardiogenic Shock: a Prospective National Registry to Get Insights in Patients' Profile, Management and Outcome","All consecutive CS patients hospitalized in the above reported centres between January 2020 and December 2030.\n\nCardiogenic shock is defined as:\n\n1. Systolic blood pressure (SBP) \\\u003C90 mmHg or mean arterial pressure (MAP) \\\u003C60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \\> 90 mmHg or MAP \\> 60 mmHg, OR need of MCS;\n2. At least one of the following criteria\u002Fsigns of overt hypoperfusion: mixed venous oxygen saturation \\\u003C60%; arterial lactates \\> 2 mmol\u002FL; oliguria \\\u003C 0.5 ml\u002FKg\u002Fh for at least 6 hours.",{"count":515,"type":22},3000,"1 Day","The study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the Intensive Coronary Care Units",[28],[105],"2026-05-13",{"date":522,"type":36},"2026-05-14",{"date":524,"type":36},"2020-07-01",{"date":526,"type":22},"2031-12-31",{"name":528,"class":43},"Niguarda Hospital",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":4},"100638928","phase-2-randomized-evaluation-of-istaroxime-for-stabilization-in-acute-heart-failure-cardiogenic-shock-100638928","NCT07583446","Randomized Evaluation of Istaroxime for Stabilization in Acute Heart Failure-Cardiogenic Shock","A Randomized, Double-blind, Phase 2b\u002F3 Clinical Study of Istaroxime Combined With Standard Care Versus Placebo and Standard of Care for the Treatment of Cardiogenic Shock (CS) Society for Cardiovascular Angiography and Interventions (SCAI) Stage B or C Due to Acute Heart Failure (AHF)","RESCUE HF-CS","Inclusion Criteria:\n\n1. Aged between 18 and 80 years old (inclusive) at the time of informed consent, regardless of gender.\n2. Diagnosed with CS SCAI B or C due to AHF during screening, before randomization, as defined by:\n\n   1. Dyspnea at rest or with minimal activity before screening and randomization.\n   2. Pulmonary rales, or lower limb edema by physical examination.\n   3. Evidence of pulmonary congestion by chest X-ray, CT scan or lung ultrasound\n   4. At the time of screening and just prior to randomization either:\n\n      1. systolic BP ≤ 100 mmHg or\n      2. systolic BP ≤ 115 mmHg and \\>100 mmHg accompanied by at least one sign of hypoperfusion or hemodynamic compromise: cool extremities, altered mentation attributable to low output, oliguria, elevated lactate (\\>2 mmol\u002FL), worsening renal function attributable to low perfusion, or invasive\u002Fnoninvasive hemodynamic evidence of reduced cardiac output.\n3. Admitted for AHF within 20 hours before randomization.\n4. Documented history within 6 months prior to screening, or during the current admission, of left ventricular ejection fraction (LVEF) \\\u003C 40%.\n5. New York Heart Association (NYHA) functional class ≥ II at 1 month prior to admission.\n6. N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\> 1,500 pg\u002FmL or BNP \\> 400 pg\u002FmL during screening, before randomization.\n7. Signed informed consent as described in Section 11.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n1. Body weight \\\u003C 40 kg or ≥ 150 kg at Screening.\n2. Society for Cardiovascular Angiography and Interventions (SCAI) level D or more severe cardiogenic shock during screening, prior to randomization.\n3. Patients with any systolic blood pressure measurement \\>130 mmHg within 2 hours prior to randomization.\n4. Administration during the 6 hours prior to screening of vasodilators such as nitroglycerin, nitrates, recombinant human brain natriuretic peptide\n5. Prescription of digoxin within 7 days before randomization.\n6. Patients with severe lung disease (dependent on oral steroids or immunosuppressive therapy or require home oxygen therapy), respiratory failure, or severe pulmonary hypertension.\n7. Acute ischemic or hemorrhagic cerebral infarction or transient ischemic attack within 30 days before screening.\n8. Abnormal laboratory findings including during screening:\n\n   1. Renal impairment (eGFR \\\u003C 25 ml\u002Fmin\u002F1.73 m2) or the need for long-term or intermittent renal support therapy (hemodialysis, ultrafiltration or peritoneal dialysis);\n   2. Severe electrolyte imbalance (Na+ \\\u003C120mmol\u002FL or \\>160mmol\u002FL, and\u002For K+ \\\u003C3.2mmol\u002FL or \\>5.5mmol\u002FL);\n   3. Liver function impairment (ALT and\u002For AST \\> 3 times the upper limit of the normal range and\u002For bilirubin exceeds 1.5 times the upper limit of the normal range);\n   4. Hemoglobin \\\u003C9 g\u002FdL (\\\u003C5.6 mmol\u002FL).\n9. Severe valvular stenosis that has not been surgically corrected, or moderate or severe aortic or pulmonary regurgitation.\n10. Obstructive hypertrophic cardiomyopathy or restrictive cardiomyopathy, constrictive pericarditis, cardiac tamponade, cardiomyopathy based on infiltrative disease (such as amyloidosis), accumulation disease (such as hemochromatosis, Fabry disease), myocardial dysplasia, cardiomyopathy caused by reversible causes (such as stress cardiomyopathy) or acute myocarditis.\n11. Sustained ventricular tachycardia or ventricular fibrillation within 30 days of screening and randomization.\n12. Significant bradycardia (sustained ventricular rate \\\u003C50 beats per minute), or second or third-degree atrioventricular block (except those using permanent pacemakers).\n13. Type 1 acute coronary syndrome (ACS)\u002Fmyocardial infarction (MI) in the 30 days prior to screening inclusive of the current admission.\n14. Patients who have undergone percutaneous coronary angiography or coronary artery bypass grafting or other major cardiovascular surgery including ICD and \u002F or CRT or mechanical support devices within one month before screening, or patients who are expected to require revascularization within three months after screening.\n15. Patients on mechanical circulatory support (MCS) during Screening or at the time of randomization.\n16. Patients who are expected to require heart transplantation or left ventricular assist during the study period.\n17. Patients diagnosed with malignant tumors within 1 year before signing the informed consent form or at the time of screening (excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery), or those undergoing anti-tumor treatment at the time of screening.\n18. Patients with diseases that in the opinion of the investigator may lead to mortality within 90 days from randomization.\n19. Patients who suffer from severe mental or psychological disorders, cognitive impairment, or a history of mental illness.\n20. Patients with known severe allergies or a history of severe drug or food allergic reactions, or those known to be allergic to Istaroxime or its ingredients including lactose.\n21. Patients who are pregnant, breastfeeding or planning pregnancy.\n22. Patients who cannot be guaranteed to take effective contraceptive measures from the time of signing the informed consent to the 30 days following their last exposure to study drug, or who are of childbearing potential and plan to donate sperm\u002Feggs during this period.\n23. Patients of childbearing potential without a negative highly sensitive serum pregnancy test within 24 hours before the first dose of trial intervention.\n24. Patients participating in other clinical studies and\u002For received other study intervention (study drugs or medical devices, etc.) within 30 days before signing the informed consent form, or who are still in the follow up period of other clinical studies.\n25. Patients who are unable to comply with all study requirements.",{"count":275,"type":22},[99,539],"PHASE3","The goal of this clinical trial is to learn if the drug istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure in adults. It will also learn about the safety of istaroxime. The main questions it aims to answer are:\n\n* Does istaroxime relieve participants' shortness of breath compared to a placebo?\n* Does istaroxime provide clinical benefit in terms of lowering the risk of dying, having invasive procedures, having worsening heart failure, and\u002For increasing quality of life compared to a placebo?\n* Does istaroxime increase blood pressure compared to a placebo? Researchers will compare istaroxime to a placebo (a look-alike substance that contains no drug) to see if istaroxime works to treat mild to moderate cardiogenic shock due to acute heart failure.\n\nParticipants will:\n\n* Receive a 48-hour intravenous infusion of istaroxime or placebo\n* Complete questionnaires rating their breathing and describing their quality of life\n* Return for a visit 30 and 90 days after the initial drug infusion was started",[28],"2026-05-07",{"date":520,"type":36},{"date":545,"type":22},"2026-07",{"date":547,"type":22},"2028-12",{"name":549,"class":312},"Seismic Pharmaceuticals Operations LLC",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":567,"leadSponsor":569,"locationsCount":44},"100636007","catheter-oriented-unloading-and-recovery-with-a-left-ventricular-assist-gear-efficacy-in-post-cardiotomy-cardiogenic-shock-100636007","NCT07560085","Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock","Efficacy and Safety of SynFlow Duro System in the Treatment of Post Cardiotomy Cardiogenic Shock: a Prospective, Multicenter, Single-arm Clinical Trial","COURAGE","Inclusion Criteria:\n\n* 18≤Age≤80, any sex.\n* Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery.\n\nFailure to wean from CPB is defined as failed to discontinue CPB or post-weaning CI \\\u003C2.2L\u002Fmin\u002Fm2 + PCWP \\>15mmHg, despite optimal pre-weaning management and receiving at least one high dose inotrope.\n\nRefractory cardiogenic shock is defined as a condition that occurs despite adequate fluid status and meets all the following criteria:\n\n① CI\\\u003C2.2L\u002Fmin\u002Fm2 + PCWP\\>15mmHg despite receiving at least one high dose inotrope or IABP; OR SBP \\\u003C80mmHg or MAP\\\u003C50mmHg despite receiving at least one high dose intrope + high dose norepinephrine or IABP.\n\n② Presence of at least one signs indicating hypoperfusion: decreased mentation; cold, clammy, ashen or cyanotic extremities or skin or livedo reticularis; urine output\\\u003C30ml\u002Fh or 0.5ml\u002Fkg\u002Fh; or lactate\\>2mmol\u002FL or metabolic acidosis.\n\n\\- Patient has signed the informed consent form.\n\nExclusion Criteria:\n\n* Body surface area\\>2.5m2.\n* Presence of any cardiac assist device (other than an IABP).\n* Right ventricular failure.\n* Evidence of any vascular disease or anatomy precluding placement or deployment of the device (e.g. severely calcified vessel).\n* Evidence of ventricular thrombus.\n* Moderate or severe aortic valve insufficiency\u002Fstenosis, or severe aortic valve calcification.\n* Presence of mechanical aortic valve or cardiac contractile device.\n* Obstructive, hypertrophic cardiomyopathy.\n* Presence of uncorrected ventricular septal defect, atrial septal defect or patent foramen ovale.\n* Mechanical manifestation of AMI (e.g. ventricular septal rupture, papillary muscle rupture, ventricular rupture).\n* Any hematological disorder causing fragility of blood vessel or hemolysis.\n* Known allergy or intolerant to heparin.\n* Presence or suspicion of active systemic infection.\n* Cardiopulmonary resuscitative maneuver lasting longer than 20 minutes before device placement.\n* Sustained or non-sustained ventricular tachycardia or ventricular fibrillation unresponsive to medical therapy.\n* Severe hepatic dysfunction, renal failure or severe respiratory failure\n* Pregnant or lactating female.\n* Concomitant enrollment in another investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation.\n* Other conditions considered unsuitable for participating in this investigation by the investigators.",{"count":559,"type":22},60,[25],"This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the treatment of post cardiotomy cardiogenic shock.",[28],"2026-05-06",{"date":565,"type":36},"2026-05-11",{"date":502,"type":22},{"date":568,"type":22},"2027-06",{"name":570,"class":312},"ForQaly Medical (Shanghai) Co., Ltd",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":589,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":605,"leadSponsor":607,"locationsCount":44},"100640195","feasibility-of-protocolised-analgosedation-in-ecmo-100640195","NCT07580781","Feasibility of Protocolised Analgosedation in ECMO","Feasibility of a Cluster Randomised Control Trial Evaluating a Co-designed Analgosedation Protocol in Extracorporeal Membrane Oxygenation (ECMO) Patients","ECMO-SED","Inclusion Criteria:\n\n* Aged 18 years and older\n* Receiving IV continuous infusions of analgosedation medication\n* Receiving ECMO treatment\n\nExclusion Criteria:\n\n* There will be no exclusion criteria as analgosedation management is routine for all adult ECMO patients.",{"count":559,"type":22},[25],"Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. Investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\nTo see whether it is possible to run a trial that compares using a sedation protocol against usual care.\n\nDesign\u002Fmethods:\n\nThirty to 60 ECMO patients will be chosen and will be put into one of two groups. One group will receive usual care, and the other will receive care using the sedation protocol. The investigators will collect information from both groups to find out if the study design works and how many patients agree to take part.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family member participants which helped to design this proposal, the lay summary and what to measure in a trial. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[583,584,585,357,586,28,587,588],"Intensive Care (ICU)","Respiratory Distress Syndrome (RDS)","Sedation and Analgesia","Sedation for Mechanical Ventilation","Opioid Analgesia","Analgesia",[590,591,592,593,594,595,232,596,597,598,599,600],"extracorporeal membrane oxygenation","sedation","opioid","sedative","analgosedation","mechanical ventilation","ICU","Intensive Care Unit","Critical Care","sedation protocol","analgesia","2026-05-05",{"date":603,"type":36},"2026-05-12",{"date":170,"type":22},{"date":606,"type":22},"2027-08-31",{"name":608,"class":43},"Guy's and St Thomas' NHS Foundation Trust",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":577,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":629,"locationsCount":44},"100595479","improving-sedation-practice-in-critically-ill-adult-patients-using-a-co-designed-sedation-protocol-100595479","NCT07032987","Improving Sedation Practice in Critically Ill Adult Patients Using a Co-designed Sedation Protocol","Optimising Analgosedation in Extracorporeal Membrane Oxygenation (ECMO) Using a Co-designed Analgosedation Protocol","Stage 1 (multi-centre observational study):\n\nInclusion Criteria:\n\n1. Aged 18 years and older.\n2. Receiving continuous IV infusions of analgosedation (opioids, benzodiazepines, and\u002For propofol).\n3. Receiving ECMO for moderate to severe respiratory failure (PaO2\u002FFiO2 (P\u002FF) ratio \\\u003C20 kilopascals (kPa)) for ≤ 7 days during the week of recruitment.\n4. Non-ECMO ICU patients (control group): must satisfy inclusion criteria 1 and 2, and have received mechanical ventilation for moderate to severe respiratory failure (P\u002FF ratio \\\u003C 20kPa) for at least 48 hours OR mechanical ventilation for cardiovascular disorder (out of hospital cardiac arrest, following cardiothoracic or transplant surgery or percutaneous coronary intervention or acute heart failure).\n\nExclusion Criteria:\n\n1. Anticipated length of ICU stay in recruiting centre for less than 24 hours.\n2. Withdrawal of life-sustaining treatment in the next 24 hours.\n\nStage 2 (mixed methods study):\n\nInclusion Criteria:\n\n1. Healthcare professionals working at one of two ECMO centres (St Thomas' Hospital and Royal Brompton Hospital (part of Guy's and St Thomas' NHS Foundation Trust).\n2. ECMO survivors (patients admitted to ICU and survived ECMO organ support) who have returned home, and recovered.\n3. Family members of ECMO survivors, whose relative is no longer hospitalised.\n\nExclusion Criteria:\n\n1. ECMO survivors currently receiving treatment in hospital.\n2. ECMO survivors with severe cognitive issues (issues with short-term memory and thinking).\n3. ECMO survivors who cannot communicate in English.\n4. Non-ECMO survivors and family members.","100 Years",{"count":618,"type":22},120,"Sedation (painkillers and sedative drugs) treats pain, reduces suffering, and helps patients in the intensive care unit (ICU) receiving extracorporeal membrane oxygenation (ECMO) remain comfortable. ECMO is a life support machine that provides oxygen and removes waste gases (carbon dioxide) in very sick patients with severe heart or lung failure. About 300-400 patients per year receive ECMO in the UK. These patients are younger and generally more healthy compared to other critically ill patients. However patients that survive ECMO have long-term health problems. These include anxiety, memory problems, withdrawal from medicines, and mobility issues. These problems issues could all be related to the type and amount of sedation given.\n\nA sedation protocol is a way of guiding healthcare professionals how much sedation is given to patients in ICU. Too much sedation can cause confusion, hallucinations, excessive sleepiness, and longer time in hospital. Too little sedation can cause pain, distress, and also a longer time in hospital. Using a sedation protocol in non-ECMO patients has been shown to reduce these complications.\n\nHowever, there are no protocols for giving sedation to ECMO patients in research papers. The investigators know healthcare staff find it difficult to manage sedation, and higher amounts of sedation is given to ECMO patients.\n\nAims:\n\n* To describe current sedation use in ECMO patients in the UK and compare to non-ECMO critically ill patients.\n* To develop a sedation protocol for ECMO patients with input from patients, their family, and staff.\n\nDesign\u002Fmethods:\n\nStudy 1:\n\nThe investigators will study how sedation is used in adult ECMO patients and compare with non-ECMO but critically ill patients in the UK. The investigators will collect information on drug doses and pain and sedation scores. The investigators will also ask ECMO centres if they use a sedation protocol to adjust sedation doses. This information will be helpful for the design of the protocol in study 2.\n\nStudy 2:\n\nThe investigators will design a sedation protocol with input from patients, family, and staff. The investigators will organise meetings to share experiences and agree on what to include in the protocol that is considered acceptable and safe. The investigators will then assess if the protocol is safe and acceptable with staff outside the co-design group.\n\nPatient and public involvement\u002Fengagement:\n\nThe investigators received feedback from patients and family members which helped to design this proposal, the lay summary and what to measure in a trial. Patients and family members will continue to help with development of the sedation and trial protocol. They will advise how the investigators should review study findings, and support sharing of results to the public.\n\nImpact\u002Fdissemination:\n\nThe investigators will share findings through social media, patient charities, research papers and conferences.",[621,584,585,622,586,28,587,588],"Intensive Care Medicine","ExtraCorporeal Membrane Oxygenation (ECMO)",[590,591,592,624,594,595,232,596,597,598,599,600],"sedatives",{"date":482,"type":36},{"date":627,"type":36},"2025-11-24",{"date":606,"type":22},{"name":608,"class":43},{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":23,"phases":639,"briefSummary":640,"conditions":641,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":288},"100462166","transcatheter-mitral-valve-repair-for-inotrope-dependent-cardiogenic-shock-100462166","NCT05298124","Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock","MINOS","Inclusion Criteria:\n\n1. Participants or substitute decision maker is able and willing to provide written informed consent\n2. Age ≥ 18 years\n3. SCAI stage C or D cardiogenic shock with persistent inotrope\u002Fvasopressor\u002Fnon-durable mechanical support or unable to wean ventilatory support due to pulmonary edema for 24 hours prior to randomization\n4. Greater than or equal to 3+ MR as determined by a study center's transesophageal echocardiogram (TEE)\n5. In the opinion of the study center's heart team the participant is anatomically eligible for TMVr with the potential to achieve \\\u003C3+ MR\n\nExclusion Criteria:\n\n1. Unwilling or unable to obtain informed consent from the participant or substitute decision maker\n2. Revascularization of coronary artery disease performed in the 48 hours prior to randomization\n3. If the mechanism of MR is deemed to be degenerative, in the opinion of the heart team the participant is eligible for surgical intervention\n4. Prior mitral valve leaflet surgery or implanted mitral valve prosthesis (excluding ring)\n5. Echocardiographic evidence of left sided intracardiac mass or thrombus\n6. Diagnosis of active infective endocarditis\n7. Transesophageal echocardiogram is contraindicated\n8. Mitral valve anatomy deemed contraindication to TMVr implantation that cannot be addressed procedurally as determined by the study center's heart team\n9. Any aortic valve disease greater than moderate in severity\n10. A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically\n11. Out of hospital cardiac arrest or in-hospital cardiac arrest without documented neurologic recovery\n12. Plan for durable mechanical circulatory support implantation prior to TMVr\n13. In the opinion of the treating team, there is a significant comorbidity that would limit life expectancy in hospital\n14. Pregnant or planning to become pregnant in the next 6 months.",{"count":638,"type":22},144,[25],"Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock.\n\nThis study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited.\n\nThe study aims to answer the question: \"Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?\"\n\nThe study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.",[28,642],"Mitral Regurgitation","2026-04-29",{"date":563,"type":36},{"date":646,"type":36},"2022-05-26",{"date":504,"type":22},{"name":174,"class":43},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":18,"minAge":656,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":44},"100636226","assessing-catecholamine-treatment-initiation-options-norepinephrine-vs-dopamine-for-cardiogenic-shock-100636226","NCT07562932","Assessing Catecholamine Treatment Initiation Options: Norepinephrine vs Dopamine for Cardiogenic Shock","ACTION-CS","Inclusion Criteria: 1\\&2\n\n1. Age ≥ 19\n2. Cardiogenic shocka in the stage of Society for cardiovascular angiography and intervention (SCAI) C or D\n\n   * Cardiogenic shock was defined as follows, and should fulfill both 1) and 2)\n\n     1. systolic blood pressure \\\u003C90 mm Hg for ≥30 min or need of inotropes or vasopressors to maintain systolic blood pressure \\>90 mm Hg And\n     2. Impaired cardiac function confirmed by cardiac catheterization or echocardiography\n   * Patients will be further classified based on the SCAI shock classification system as follows:\n\n     1. SCAI B: no signs of hypoperfusion\n     2. SCAI C: any signs of hypoperfusion, cardiogenic shock will be classified as SCAI C, and these include mental status change, cool and clammy skin, mottled skin appearance, decreased urine output (30ml\u002Fhour) or lactate over 2.0mmol\u002FL\n     3. SCAI D: requirement of second-line vasoactive drug or mechanical circulatory support based on the predefined treatment protocol\n\nExclusion Criteria: any of these,\n\n1. Administration of vasoactive drug more than 6 hours before enrollment\n2. Patients already on temporary mechanical circulatory supportb before enrollment\n3. Glasgow Coma Scale lower than 8 or other evidence of irreversible brain injury\n4. Shock etiologies other than cardiogenic which include postcardiotomy shock or mixed shock\n5. Pregnancy or lactation","19 Years",{"count":658,"type":22},512,[25],"The goal of this multicenter, open-label, randomized clinical trial is to learn whether norepinephrine or dopamine is more effective and safer as the first-line vasoactive drug for treating cardiogenic shock in adults. Cardiogenic shock is a life-threatening condition in which the heart cannot pump enough blood to supply the body. The main questions this study aims to answer are:\n\nDoes norepinephrine reduce the risk of death or worsening cardiogenic shock compared with dopamine?\n\nDoes norepinephrine lead to fewer complications such as arrhythmias, the need for mechanical circulatory support, or cardiac arrest?\n\nResearchers will compare norepinephrine and dopamine to see which drug better stabilizes blood pressure, improves tissue perfusion, and prevents progression of shock during the early phase of treatment.\n\nParticipants will:\n\nBe randomly assigned to receive either norepinephrine or dopamine as the first vasoactive drug\n\nReceive treatment and monitoring based on current clinical guidelines for cardiogenic shock\n\nUndergo regular assessments of blood pressure, laboratory values, heart rhythm, and organ function during hospitalization\n\nBe followed for outcomes at 1 month, 6 months, and 1 year after enrollment\n\nThis study aims to provide evidence that will help determine which initial vasoactive drug offers better outcomes for patients with cardiogenic shock and guide future treatment recommendations.",[28],[663,664,665,666,143],"Vasoactive drug","Norepinephrine","Dopamine","Randomized controlled trial","2026-04-28",{"date":669,"type":36},"2026-05-01",{"date":671,"type":22},"2026-05-31",{"date":673,"type":22},"2032-05-31",{"name":675,"class":43},"Chonnam National University Hospital"]