[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiorenal-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiorenal-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,82,111,135,156,192,221,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644241","cardiorenal-syndrome-characteristics-and-prognostic-impact-in-advanced-heart-failure-100644241",false,"NCT07666516","Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure","CARAVEL","Inclusion Criteria:\n\n* Written informed consent signed by the patient,\n* Age ≥ 18 years and ≤ 75 years,\n* Patient with advanced heart failure confirmed by criteria of severe cardiac dysfunction documented in a stable condition, with at least one of the following parameters at baseline:\n\n  * LVEF ≤ 35%,\n  * Elevated BNP or NT-proBNP levels (\\>200 ng\u002FL for BNP and \\>1000 ng\u002FL for NT-proBNP),\n* NYHA class ≥ 3,\n* At least one hospitalization for heart failure decompensation within the past 24 months,\n* Optimized medical treatment for heart failure according to French\u002FEuropean cardiology guidelines at the maximum tolerated dose for \\>30 days.\n\nExclusion Criteria:\n\n* Presence of severe extracardiac disease with a life expectancy \\\u003C 1 year,\n* Patient with end-stage renal disease (GFR \\\u003C15 mL\u002Fmin\u002F1.73 m²) or on dialysis,\n* History of heart, kidney, or other solid organ transplantation,\n* Patient in cardiogenic shock,\n* INTERMACS profile ≤ 3,\n* Pregnant, parturient, or breastfeeding women\\*,\n* Individuals deprived of liberty by judicial or administrative decision,\n* Individuals under psychiatric care,\n* Individuals admitted to a health or social institution for purposes other than research,\n* Adults under legal protection (guardianship or curatorship),\n* Individuals not affiliated with a social security system or equivalent coverage.\n* Contraindication to multiparametric renal MRI combined with tissue sodium measurement using non-contrast 23Na MRI of the leg (including inability to undergo MRI as judged by the investigator).","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Advanced heart failure (AHF) represents the end stage of chronic heart failure with reduced ejection fraction and affects up to 10% of patients with heart failure. These patients have refractory disease despite optimal guideline-directed medical therapy, and their management is discussed within a multidisciplinary \"Heart Team\".\n\nRenal dysfunction is highly prevalent in this population. The coexistence of cardiac and renal dysfunction has been classified under the entity of cardiorenal syndrome. Impaired renal function is an independent predictor of adverse cardiovascular and renal outcomes, including death, heart failure decompensation, worsening renal function, and the need for renal replacement therapy. However, patients with AHF remain a particularly complex population, and the lack of longitudinal biological data and limited understanding of the dynamics of cardiorenal syndrome in relation to therapeutic interventions make prognosis assessment and individualized management challenging.\n\nIn addition, little is known about renal tubular function in AHF, despite its central role in hydro-electrolytic balance regulation. Biomarkers of tubular injury such as neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) have shown prognostic value in therapeutic studies, but their relationship with cardiac function and outcomes in advanced heart failure remains insufficiently characterized.\n\nThe primary objective of this study is to evaluate renal function parameters and their evolution over time through measurement of glomerular filtration rate (GFR) and assessment of tubular function in patients with advanced heart failure, and to investigate their association with major adverse cardiovascular events.\n\nThis is a prospective, single-center RIPH2 cohort study including 100 patients aged 18 to 75 years managed for advanced heart failure at the Louis Pradel Cardiovascular Hospital (Hospices Civils de Lyon, France). Patients will be followed according to standard care at 6, 12, 18, and 24 months. More comprehensive nephrological and cardiological evaluations will be performed at baseline, 12 months, and 24 months. Biobanking and quality-of-life questionnaires will also be conducted during these visits. Blood and urine samples will be collected at baseline and 12 months for NGAL et KIM-1 analysis. In addition, a subgroup of 50 consenting patients without contraindications will undergo multiparametric non-contrast renal MRI combined with tissue sodium quantification using 23Na MRI of the leg.",[27,28],"Advanced Heart Failure","Cardiorenal Syndrome",[30,31,32],"advanced heart failure","cardiorenal syndrome","biomarkers","NOT_YET_RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":21},"2026-09-01",{"date":41,"type":21},"2031-11-15",{"name":43,"class":44},"Hospices Civils de Lyon","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100491282","diuretics-alone-vs-aortix-endovascular-device-for-acute-heart-failure-100491282","NCT05677100","Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure","DRAIN-HF: Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure","DRAIN-HF","Inclusion Criteria (Randomized Study):\n\n* Currently admitted to the hospital with a primary diagnosis of decompensated heart failure, irrespective of ejection fraction (EF);\n* Patients should be on maximally tolerated diuretic therapy and not diuresing sufficiently before being enrolled in DRAIN-HF. After being up-titrated on diuretics, patients should be followed for at least 24 hours on the higher of: i) furosemide 80 mg IV bid or equivalent or ii) IV furosemide or equivalent IV loop diuretic at a dose 2.5 x total daily home dose of furosemide equivalents in 2 divided doses, as tolerated, patient must have: Urine Output \\\u003C1,500mL in a 12-hour period OR a Net Fluid Loss ≤375mL in a 12-hour period.\n* Persistent signs and\u002For symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \\>12 cm water or ascites after treatment with IV diuretics per inclusion criterion 2.;\n* Age \\>21 years and able to provide written informed consent;\n* Negative pregnancy test if patient is of child-bearing potential.\n\nExclusion Criteria (Randomized Study):\n\n* Treatment with high dose IV inotropes within the last 48 hours prior to enrollment. High dose is defined as \\>5 µg\u002Fkg\u002Fmin dopamine OR \\>5 µg\u002Fkg\u002Fmin dobutamine OR \\>0.375 µg\u002Fkg\u002Fmin milrinone;\n* Active and ongoing hypotension with a systolic blood pressure \\\u003C90 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \\\u003C60 mmHg lasting more than 30 minutes at enrollment;\n* Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment;\n* An estimated PASP of \\>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure;\n* Acute kidney failure defined as an increase in serum creatinine to ≥4.0mg\u002FdL (≥353.6 µmol\u002FL) at enrollment;\n* Evidence of contrast induced nephropathy, nephritis or nephrotic syndrome;\n* Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT) or ultrafiltration in the last 90 days prior to enrollment;\n* Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \\> 1000U\u002FL or total Bilirubin \\> 5.0mg\u002Fdl) at enrollment;\n* Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device;\n* Prior heart transplant or likely heart transplantation before the 30- day follow-up visit;\n* Current or previous support with a durable LVAD at any time or planned LVAD insertion before the 30-day follow-up visit;\n* Use of an intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g. Impella or TandemHeart) within the last 30 days;\n* Confirmed diagnosis of AL amyloidosis;\n* Acute myocardial infarction Type 1 within 30 days of enrollment, or planned coronary revascularization in the next 30 days;\n* Stroke within 30 days of enrollment;\n* Severe Bleeding Risk (any of the following):\n\n  1. Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days,\n  2. GI bleeding within 6 months requiring hospitalization and\u002For transfusion,\n  3. Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding,\n  4. Procedure with arterial ilio-femoral access \\> 6 FR within 30 days,\n  5. Platelet count \\\u003C75,000 cells\u002Fmm3,\n  6. Uncorrectable bleeding diathesis or coagulopathy (e.g. INR ≥2 not due to anticoagulation therapy) or hypercoaguable state including HIT;\n  7. Inability to tolerate anticoagulation therapy for up to 7 days.\n* Contraindicated Anatomy :\n\n  1. Descending aortic anatomy that would prevent safe placement of the device \\[\\\u003C18 mm or \\>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\\],\n  2. Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath,\n  3. Femoral artery depth inconsistent with use of closure device,\n  4. Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g. aneurysm with thrombus, marked tortuosity, significant narrowing or inadequate size of the abdominal aorta, iliac or femoral arteries, or severe calcification),\n  5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury,\n  6. Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction\u002Fremoval of the Aortix pump as demonstrated by imaging.\n* Known hypersensitivity or contraindication to study or procedure medications (e.g. anticoagulation therapy) or device materials (e.g. history of severe reaction to nickel or nitinol);\n* Participation in any other clinical investigation that is likely to confound study results or affect the study;\n* Poor health such that the patient is unable to undergo the Aortix device placement\u002Fretrieval and\u002For unlikely to be able to survive to the 30-day visit;\n* Unable or unwilling to undergo screening (imaging, PA Catheter placement), device implant and retrieval procedures or return for 30-day visit.\n\nInclusion Criteria (Advanced Heart Failure Registry):\n\n* Currently admitted to the hospital with a primary diagnosis of decompensated HF, irrespective of ejection fraction (EF).\n* Patient has already been evaluated and indicated to receive an LVAD or heart transplant and will receive the LVAD or be listed for heart transplantation in the next 30 days if their congestion status and renal function improves.\n* Patient must have been treated with ≥ 80 mg IV furosemide bid or equivalent and have evidence of increasing diuretic dosing requirements over the past 12 months, as tolerated.\n* Must have evidence of refractoriness to medical management as documented by persistent signs and\u002For symptoms of congestion as evidenced by at least 2+ pitting edema, elevated jugular venous pressure \\>12 cm water, or ascites after treatment with IV diuretics for a minimum of 24 hours.\n* Serum creatinine ≥ 2.0 mg\u002FdL AND eGFR ≤ 45 ml\u002Fmin\u002F1.73m2 at time of enrollment\n* Age ≥ 21 years and able to provide written informed consent.\n* Negative pregnancy test if patient is of childbearing potential.\n\nExclusion Criteria (Advanced Heart Failure Registry):\n\n* Treatment with high dose IV inotropes within 48 hours prior to enrollment. High dose is defined as any one of the following: \\>5 µg\u002Fkg\u002Fmin dopamine OR \\>5 µg\u002Fkg\u002Fmin dobutamine OR \\>0.375 µg\u002Fkg\u002Fmin milrinone.\n* Active and ongoing hypotension with a systolic blood pressure \\\u003C80 mmHg lasting more than 30 minutes or a mean arterial pressure (MAP) \\\u003C55 mmHg lasting more than 30 minutes at enrollment.\n* Treatment with vasopressors (defined as phenylephrine, norepinephrine, epinephrine or, vasopressin) within 48 hours prior to enrollment.\n* An estimated PASP of \\>80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure.\n* Acute kidney failure defined as an increase in serum creatinine to ≥ 4.0mg\u002FdL at enrollment.\n* Evidence of contrast-induced nephropathy, nephritis, or nephrotic syndrome.\n* Prior kidney transplant, single kidney, partial nephrectomy OR use of dialysis, continuous renal replacement therapy (CRRT), or ultrafiltration in the last 90 days prior to enrollment.\n* Confirmed decompensated cirrhosis (defined as Child Pugh class B or C) or concern for shock liver (AST \\> 1000U\u002FL or total Bilirubin \\> 5.0mg\u002Fdl) at enrollment.\n* Presence of an active, uncontrolled infection that would preclude safe placement or removal of the device.\n* Current or previous support with a durable LVAD.\n* INTERMACS Profile 1 at enrollment.\n* Currently on mechanical ventilatory support.\n* Use of an intra-aortic balloon pump (IABP) within the last 14 days or use of an extracorporeal membrane oxygenation (ECMO) or percutaneous ventricular assist device (e.g., Impella or TandemHeart) within the last 30 days.\n* Confirmed diagnosis of AL amyloidosis.\n* Acute myocardial infarction Type 1 within 30 days of enrollment or planned coronary revascularization in the next 30 days.\n* Stroke within 30 days of enrollment.\n* Severe Bleeding Risk (any of the following):\n\n  * Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 7 days.\n  * GI bleeding within 6 months requiring hospitalization and\u002For transfusion.\n  * Recent major surgery within 30 days if the surgical wound is judged to be associated with an increased risk of bleeding.\n  * Procedure with arterial ilio-femoral access \\> 6 Fr within 30 days.\n  * Platelet count \\\u003C75,000 cells\u002Fmm3 .\n  * Uncorrectable bleeding diathesis or coagulopathy (e.g., INR≥ 2 not due to anticoagulation therapy) or hypercoagulable state including HIT.\n  * Inability to tolerate anticoagulation therapy for up to 7 days.\n* Contraindicated Anatomy :\n\n  * Descending aortic anatomy that would prevent safe placement of the device \\[\\\u003C18 mm or \\>31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)\\].\n  * Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21 Fr (outer diameter) introducer sheath.\n  * Femoral artery depth inconsistent with use of closure device.\n  * Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification).\n  * Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury.\n  * Any endovascular stent graft in the descending aorta. Any endovascular stent graft in the femoro-iliac vessels that is not well endothelialized and would preclude safe introduction\u002Fremoval of the Aortix pump as demonstrated by imaging.\n* Known hypersensitivity or contraindication to study or procedure medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol).\n* Participation in any other clinical investigation that is likely to confound study results or affect the study.\n* Poor health such that the patient is unable to undergo the Aortix device placement\u002Fretrieval and\u002For unlikely to be able to survive to the 30-day visit.\n* Unable or unwilling to undergo screening, device implant and retrieval procedures, or return for 30-day visit.","21 Years",{"count":56,"type":21},320,[24],"Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.\n\nEligible ADHF patients with diuretic resistance (irrespective of ejection fraction) will be enrolled and randomized 1:1 to either the Aortix system or standard of care medical management.",[60,28,61,62,63,64,65,66],"Heart Failure","Cardio-Renal Syndrome","ADHF","Heart Failure, Systolic","Heart Failure, Diastolic","Heart Failure; With Decompensation","Heart Failure, Congestive",[68,69],"mechanical circulatory support","percutaneous","RECRUITING","2026-06-05",{"date":73,"type":37},"2026-06-09",{"date":75,"type":37},"2023-08-23",{"date":77,"type":21},"2027-08",{"name":79,"class":80},"Procyrion","INDUSTRY",48,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":109,"locationsCount":45},"100349951","feasibility-of-the-scd-in-cardiorenal-syndrome-patients-awaiting-lvad-100349951","NCT03836482","Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD","Feasibility Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute on Chronic Systolic Heart Failure With Worsening Renal Function Due to Cardiorenal Syndrome or Severe Right Ventricular Failure Awaiting Left Ventricular Assist Device Implantation","NEUTRALIZE-CRS","Inclusion Criteria:\n\n1. Age of 18 years and older.\n2. Evidence of systemic inflammation: blood CRP ≥ 4.5 mg\u002FL or IL-6 ≥ 5.0 pg\u002Fml or neutrophil to lymphocyte ratio ≥3.0.\n3. Primary hospitalization for acute decompensated chronic systolic heart failure.\n4. Potential LVAD candidate with:\n\n   a) Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure b) NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or ARB or valsartan\u002Fsacubitril, aldosterone antagonist, SGLT2i, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days c) Known previous peak exercise oxygen consumption \\\u003C 14 mL\u002FKg\u002Fmin or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)\n5. Baseline eGFR\\*\\* ≥ 40 ml\u002Fmin\u002F1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)\n6. At least one of the following two criteria:\n\n   1. Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria -Central venous pressure \\> 16 mmHg\n\n      -Central venous pressure\u002FPulmonary wedge pressure \\>0.65\n\n      -Right ventricular stroke work index \\\u003C 300 mmHg \\* ml\u002Fm2\n\n      -Pulmonary artery pulsatility index (PAPi) \\\u003C 2,\n   2. Worsening renal failure (WRF), defined for the purposes of this study as -Increase serum creatinine ≥ 0.5 mg\u002FdL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment) AND\n\n      * eGFR\\*\\* ≤ 30 ml\u002Fmin\u002F1.73 m2 based on serum creatinine at enrollment\\*\\*\\* AND\n      * Cardiorenal syndrome is the most likely explanation for WRF AND\n      * Intolerant or inadequately responsive to standard of care diuretic therapy, defined as persistent signs and\u002For symptoms of congestion (e.g., peripheral edema, dyspnea, pulmonary rales, neck vein distension) or minimal net volume removal in a 24-hour period despite optimal medical therapy including intravenous diuretic therapy and an estimated need for \\>5kg fluid removal.\n\n        1. Optimal intravenous diuretic therapy is defined as:\n\n           1. Furosemide equivalent total daily dose of 240mg\n           2. Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion\n           3. A furosemide equivalent total daily dose \\\u003C240mg if the dose has resulted in \\>3000 mL urine output\u002F24 hours.\n7. PA catheter in place at the time of enrollment\n8. PCW ≥ 20 mmHg\n\n   * eGFR calculated using the CKD-EPI Creatinine Equation \\*\\*\\* Recognizing that this is not a steady state creatinine\n\nExclusion Criteria:\n\n1. Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status\n2. Prior sensitivity to dialysis device components\n3. Active bacteremia\n4. Temperature ≥ 101.5 F or WBC ≥ 10,000 K\u002FuL or any patient with suspected systemic infection.\n5. Metastatic malignancy requiring palliative chemo, biologic, or radiation\n6. Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine \\> 3 mcg\u002Fkg\u002Fmin. (Note: use of vasodilating inotropes \\[i.e., dobutamine and milrinone\\] or dopamine at ≤ 3 mcg\u002Fkg\u002Fmin will not preclude study inclusion)\n7. Patients requiring mechanical ventilatory support\n8. Patients requiring total parenteral nutrition during the treatment period\n9. Persistent SBP \\\u003C 80 mmHg\n10. WBC \\\u003C 4000 K\u002FuL\n11. Platelets \\\u003C 100,000K\u002FuL\n12. Serum creatinine \\> 4 mg\u002FdL or receiving dialysis \u002F CRRT\n13. Acute coronary syndrome within the past month\n14. Women who are pregnant, breastfeeding a child, or trying to become pregnant\n15. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and\u002For samples are taken (i.e., no test device or test drug used) are allowed to participate\n16. Use of any other investigational drug or device within the previous 30 days. Patients who participated in a clinical study where only measurements and\u002For samples are taken (i.e., no test device or drug used) are allowed to participate.",{"count":91,"type":21},20,[24],"Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.\n\nThis study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.",[95,28],"Acute on Chronic Systolic Congestive Heart Failure",[97,98,99,100,101,102],"Awaiting Left ventricular assist device implantation","Hospitalized","Selective Cytopheretic Device","SCD","LVAD","CRS","2026-03-30",{"date":105,"type":37},"2026-03-31",{"date":107,"type":37},"2025-10-02",{"date":77,"type":21},{"name":110,"class":80},"SeaStar Medical",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100629217","monitoring-of-the-sympatheticvagal-balance-through-multiparametric-analysis-of-heart-rate-variability-hrv-100629217","NCT07471802","Monitoring of the Sympathetic\u002FVagal Balance Through Multiparametric Analysis of Heart Rate Variability (HRV)","Monitoring of the Sympathetic\u002FVagal Balance Through Multiparametric Analysis of Heart Rate Variability (HRV) in Patients With Type 2 Diabetes Mellitus (Type 2 DM), With or Without Heart Failure and\u002For Chronic Kidney Disease, or Cardiomyopathy, With Heart Failure and\u002For Cardio-renal Syndrome, All Receiving Optimized Pharmacological Treatment, Including a Sodium-Glucose Co-transporter 2 Inhibitor (SGLT2i).","GLIFO-HRV","Inclusion Criteria:\n\n* Age over 18 years;\n* Signed informed consent;\n* in Sinus rhythm;\n* Patients for whom HOLTER ECG monitoring is clinically indicated, to early identify the possible onset or progression of diabetic autonomic neuropathy, or ischemic changes, or potentially arrhythmogenic electrophysiological alterations;\n* On optimized pharmacological treatment according to clinical practice, naïve to SGLT2 inhibitor therapy, prescribed according to the (1A) recommendations of the ESC 2023 guidelines.\n\nExclusion Criteria:\n\n* Patients with atrial fibrillation or other arrhythmic burden incompatible with accurate HRV analysis;\n* Pacemaker or ICD carriers;\n* Immunodeficient patients or patients at risk of developing infections.",{"count":120,"type":21},150,"OBSERVATIONAL","The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control.\n\nReduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications.\n\nSodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters.\n\nLarge randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status.\n\nDespite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.",[124,60,125,28],"Diabete Type 2","Kidney Disease, Chronic","2026-03-20",{"date":128,"type":37},"2026-03-24",{"date":130,"type":21},"2026-03-25",{"date":132,"type":21},"2031-09-01",{"name":134,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":45},"100605811","exercise-rehabilitation-for-cardiorenal-syndrome-in-hfref-patients-100605811","NCT07167368","Exercise Rehabilitation for Cardiorenal Syndrome in HFrEF Patients","Efficacy and Safety of Home-Based Exercise Rehabilitation in Patients With Cardiorenal Syndrome Complicated by Chronic Heart Failure With Reduced Ejection Fraction (HFrEF): A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with chronically stable HFrEF complicated by kidney dysfunction (eGFR \\\u003C 90 mL\u002Fmin\u002F1.73m²)\n* NYHA class II-III\n* Low risk in exercise risk assessment\n* Aged 18-75 years\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Severe arrhythmias (including frequent ventricular premature contractions, ventricular tachycardia, rapid atrial fibrillation, sick sinus syndrome, and second-degree or higher atrioventricular block)\n* Obstructive hypertrophic cardiomyopathy\n* Moderate to severe stenotic valvular heart disease\n* Deep vein thrombosis or pulmonary embolism\n* History of syncope\n* Severe anemia\n* Abnormal thyroid function\n* Severe pulmonary diseases\n* Mental illnesses\n* Osteoarticular or muscular diseases that impede rehabilitation training",{"count":143,"type":21},60,[24],"This study aims to investigate the efficacy and safety of exercise rehabilitation in patients with cardiorenal syndrome (CRS).\n\nBuilding on previous research demonstrating that exercise rehabilitation can effectively improve cardiac function and cardiopulmonary endurance in patients with chronic heart failure, this study will further explore its role in the context of CRS, a condition where such effects remain understudied. CRS patients typically exhibit reduced cardiopulmonary endurance, with significantly lower peak oxygen uptake (VO₂ peak) and 6-minute walk test (6MWT) distance compared to non-CRS patients.\n\nAdults aged 18-75 with chronic heart failure with reduced ejection fraction (HFrEF) complicated by chronic renal insufficiency will be enrolled and randomly assigned to two groups: 1. Basic treatment group: 30 patients receive only basic drug treatment for 6 months. 2. Exercise rehabilitation group: 30 patients receive basic drug treatment combined with home-based exercise rehabilitation for 6 months (with personalized exercise prescriptions formulated based on cardiopulmonary exercise test results or 6MWT for those unable to complete the former). The study will explore the efficacy and safety of exercise rehabilitation in the prevention and management of CRS by comparing changes in target biomarkers, renal function indicators, cardiac function indicators, cardiopulmonary exercise test results, Minnesota Living with Heart Failure Questionnaire scores, and the incidence of adverse events before and after treatment between the two groups.\n\nThe participants will:\n\nComplete cardiopulmonary exercise tests or 6MWT before treatment initiation. Receive basic drug treatment; those in the exercise rehabilitation group will additionally perform home-based exercise rehabilitation according to the exercise prescription.\n\nAttend regular follow-up visits within 6 months. Undergo assessments of related indicators (biomarkers, renal function, cardiac function, etc.) before and after treatment.",[28],"2026-02-24",{"date":149,"type":37},"2026-02-27",{"date":151,"type":37},"2025-09-15",{"date":153,"type":21},"2027-12-31",{"name":155,"class":44},"Haiyan Pan",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":166,"conditions":167,"keywords":172,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100602424","french-aki-registry-fakir-a-multicenter-study-on-the-in-hospital-management-and-outcomes-of-severe-acute-kidney-injury-in-nephrology-units-100602424","NCT07123324","French AKI Registry (FAKIR): A Multicenter Study on the In-Hospital Management and Outcomes of Severe Acute Kidney Injury in Nephrology Units","Prospective Multicenter Observational Study of the Management and Prognosis of Severe Acute Kidney Injury (AKI) in Nephrology Units: The French AKI Registry (FAKIR)","FAKIR","Inclusion Criteria:\n\n* Age ≥ 18 years at admission\n* Hospitalized in a nephrology ward (standard or intensive nephrology care unit)\n* Diagnosis of acute kidney injury (AKI) stage 2 or 3 according to KDIGO criteria at the time of admission\n* Availability of follow-up data at 3 months (clinical or laboratory)\n\nExclusion Criteria:\n\n* AKI stage 1 only\n* AKI acquired outside the nephrology department without subsequent transfer to nephrology\n* Hospitalized for another reason without documented AKI stage 2 or 3\n* Refusal or opposition to data reuse for research purposes\n* Under legal protection (guardianship or trusteeship) without a representative to provide non-opposition\n* Incomplete medical records preventing collection of required baseline data",{"count":165,"type":21},750,"Acute Kidney Injury (AKI) is a common and serious condition in hospitalized patients, especially when it reaches stages 2 or 3 according to the KDIGO classification. These severe forms are associated with high mortality, a risk of progression to chronic kidney disease (CKD), and frequent cardiovascular complications. However, current data on how nephrologists manage these patients during hospitalization-and how these practices influence long-term outcomes-are limited and heterogeneous.\n\nThe FAKIR study (French AKI Registry) is a prospective, multicenter, non-interventional observational study designed to describe the clinical management of patients admitted to nephrology departments for AKI stage 2 or 3 and to assess their renal and cardiovascular outcomes up to one year. The study hypothesizes that better characterization of in-hospital practices and patient trajectories will help identify predictors of renal recovery, progression to end-stage renal disease, and major cardiovascular events.\n\nPatients will be followed during hospitalization and at 3, 6, and 12 months to assess renal function, mortality, cardiovascular events, and rehospitalizations. This registry aims to provide real-life, multicenter data to support future guidelines and the development of structured post-AKI care pathways.",[168,169,28,170,171],"Acute Kidney Injury","Kidney Failure Chronic","Renal Replacement Therapies","Hospitalizations",[173,174,175,176,177,178,179,180,181,182],"Kidney injury","Renal function recovery","Dialysis initiation","Kidney biopsy","Cardiovascular complications","Nephrology care","Renal prognosis","Renal cohort","Kidney follow-up","Kidney disease progression","2025-08-07",{"date":185,"type":37},"2025-08-14",{"date":187,"type":21},"2025-11-01",{"date":189,"type":21},"2028-08-01",{"name":191,"class":44},"University Hospital, Strasbourg, France",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":45},"100570989","venous-ultrasound-guided-organ-decongestion-in-patients-hospitalized-with-acute-decompensated-heart-failure-100570989","NCT06714409","Venous Ultrasound Guided Organ Decongestion in Patients Hospitalized with Acute Decompensated Heart Failure","A Parallel-group, Single-center, Two-arm Treatment Study to Assess the Safety and Effectiveness of Venous Ultrasound Guided Decongestion in Adult Patients Hospitalized with Acute Decompensated Heart Failure.","VExOUS-ADHF","Inclusion Criteria:\n\n* 18 years of age or above\n* Admitted the ward of Department of Cardiology OUH Ullevål with a clinical diagnosis of ADHFdefined by European Society of Cardiology\n* Pro-BNP \\> 800 ng\u002Fl at first day of admission\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n\\- Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation",{"count":201,"type":21},180,[24],"The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF).\n\n180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints.\n\nThe overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in:\n\n* differences in length of hospitalization\n* changes in biomarkers of cardiac strain\n* changes in renal function and markers of renal injury\n* achieved doses of heart failure treatment at discharge\n* in-hospital complications\n\nSafety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.",[28,60,168,205],"Acute Decompensated Heart Failure",[207,208,209,210,211],"Cardiorenal syndrome","Acute kidney injury","Heart failure","VExUS","Venous congestion","2024-11-28",{"date":214,"type":37},"2024-12-03",{"date":216,"type":37},"2024-09-16",{"date":218,"type":21},"2025-10-01",{"name":220,"class":44},"Oslo University Hospital",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":45},"100565281","effects-of-a-supervised-training-program-on-functional-capacity-in-patients-with-hf-and-cardiorenal-syndrome-100565281","NCT06640140","Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome","Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome","Train-CR","Inclusion Criteria:\n\n* Patients diagnosed with heart failure according to 2021 ESC guidelines for Heart Failure.\n* Evidence of cardiorenal syndrome, defined as coexistent very high risk chronic kidney disease (CKD) (estimated glomerular filtration rate \\[eGFR\\] \\<30 ml\u002Fmin\u002F1.73m2 or eGFR 30 to 44 ml\u002Fmin\u002F1.73m2 and Urine Albumin-Creatinine Ratio \\[uACR\\] \\>30 mg\u002Fg) or rapidly progressive CKD (loss of \\>5 ml\u002Fmin\u002F1.73m2 in one year).\n* Stable symptomatic heart failure patients (New York Heart Association functional class II-III\u002FIV) during the last month.\n* Age ≥ 18 years old.\n* Willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Inability to perform a valid baseline cardiopulmonary exercise test.\n* Significant primary severe valve disease that is considered the main symptom driver.\n* Effort angina or signs of ischemia during CPET.\n* Primary cardiomyopathies.\n* Cardiac transplantation.\n* Any other comorbidity with a life expectancy of less than one year.",{"count":230,"type":21},26,[24],"This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \\[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL\u002Fkg\u002Fmin (SD±2)\\] of 26 patients (13 per arm) would be necessary to test our hypothesis.",[60,28],[209,28,235],"Functional Capacity","2024-10-10",{"date":238,"type":37},"2024-10-15",{"date":240,"type":21},"2024-10-08",{"date":242,"type":21},"2025-12",{"name":244,"class":44},"Fundación para la Investigación del Hospital Clínico de Valencia",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":260,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":253},"100529503","feasibility-study-to-support-cardiorenal-function-in-acute-decompensated-heart-failure-with-diuretic-resistance-100529503","NCT06174623","Feasibility Study to Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance","Early Feasibility Study to Mechanically Support Cardiorenal Function in Acute Decompensated Heart Failure With Diuretic Resistance","Inclusion Criteria:\n\n1. Admitted to the hospital with a primary diagnosis of ADHF\n2. Clinical signs and\u002For symptoms of congestion defined as at least one of the following: dyspnea at rest or with minimal exertion, orthopnea, lower extremity edema (≥2+), elevated jugular venous pressure, pulmonary rales, pulmonary vascular congestion on chest x-ray, pleural effusion or ascites\n3. Projected need by the treating clinician for continued treatment with IV diuretic agents for more than 48 hours with the goal of significant fluid removal (more than 1L net fluid loss\u002F24h)\n4. Appropriate intravenous loop diuretic therapy at the time of enrollment, defined as at least the higher of:\n\n   1. Furosemide 40mg IV bid or equivalent\n   2. IV furosemide or equivalent IV loop diuretic equivalent to ≥2x the total oral daily loop diuretic dose at home in 2 divided doses\n5. Diuretic resistance defined as at least ONE of the following:\n\n   1. Urine output of less than 1.5L over 12h following the last diuretic dose, OR\n   2. Net fluid loss of less than 1L over the last 24 hours, OR\n   3. Spot urinary sodium concentration of less than 70 mmol\u002FL 2h following the last diuretic dose or cumulative 6-hour natriuresis of less than 100 mmol following the last diuretic dose, OR\n   4. Clinically unsatisfactory resolution of congestion\n6. Age ≥ 21 years old\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. ADHF related to acute secondary disease (i.e., infection or acute coronary syndrome)\n2. Treatment with high dose inotropes (milrinone ≥0.375 mcg\u002Fkg\u002Fmin, dobutamine ≥5mcg\u002Fkg\u002Fmin or dopamine ≥5mcg\u002Fkg\u002Fmin) and\u002For treatment with vasopressors to maintain a systolic arterial blood pressure ≥90 mmHg or mean arterial blood pressure ≥60 mmHg\n3. Current or previous support with a durable left ventricular assist device (LVAD) at any time or use of an extracorporeal membrane oxygenation (ECMO), percutaneous ventricular assist devices, intra-aortic balloon pump or patient on home inotropes currently or within the last 30 days\n4. Recent myocardial infarction, percutaneous coronary intervention or surgical revascularization (within the last 30 days) or awaiting planned coronary intervention or surgery\n5. Fixed pulmonary vascular resistance of more than 5 Wood units, estimated PASP of more than 80 mmHg as measured on echocardiogram or echocardiographic evidence of primarily right heart failure\n6. Prior heart transplant, heart failure due to rejection of a previous heart transplant, or planned heart transplantation\n7. Reanimated cardiac arrest in the last 30 days\n8. Suspected or known amyloid disease or other restrictive cardiomyopathy\n9. Severe bleeding risk precluding anticoagulation:\n\n   1. Previous intracranial bleed unless there is documentation in the medical record (from a physician that is not part of the study) that the patient can safely use anticoagulation for 3 days\n   2. Gastrointestinal (GI) bleeding within 1 month requiring hospitalization and\u002For transfusion\n   3. Recent major surgery within 1 month if the surgical wound is judged to be associated with an increased risk of bleeding\n   4. Platelet count of less than 50,000 cells\u002Fmm3\n   5. Uncorrectable bleeding diathesis or coagulopathy\n10. Contraindicated anatomy:\n\n    1. Descending aortic anatomy that would prevent safe placement of the device (less than 18 mm or more than 28mm thoracoabdominal aorta diameter at deployment location)\n    2. Abnormalities of the aorta or subclavian or axillary arteries that would prevent safe device placement, including aneurysms, significant tortuosity, or calcifications\n    3. Axillary artery anatomy that would preclude safe placement of a 10F sheath including severe obstructive calcification or severe tortuosity\n    4. Iliofemoral artery anatomy that would preclude safe placement of a 16F introducer sheath including severe obstructive calcification or severe tortuosity\n    5. Known connective tissue disorder (e.g. Marfan Syndrome) or other aortopathy at risk of vascular injury\n    6. Prior endovascular surgery or percutaneous intervention involving the thoracoabdominal aorta or a subclavian\u002Faxillary artery or history of aortic dissection\n11. Severe aortic stenosis\n12. Known or suspected contrast induced nephropathy\n13. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication\n14. Absolute contraindications or allergy to unfractionated heparin (e.g., heparin-induced thrombocytopenia) or device materials (e.g. nickel, titanium) that cannot be adequately treated with pre-medication\n15. Known hematologic diseases such as leukemia, any coagulopathy or hypercoagulable state, sickle cell anemia or thalassemia\n16. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:\n\n    1. Liver disease (cirrhosis of the liver \\[Child-Pugh class B or C\\]) or shock liver\n    2. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1\u002FFVC less than 0.7, and FEV1 less than 50% predicted\n    3. Prior kidney transplant, isolated single kidney, stage V Chronic Kidney Disease (eGFR ≤15) at admission OR use of dialysis, continuous renal replacement therapy (CRRT) or aquapheresis (ultrafiltration) in last 90 days\n17. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n18. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 90 days prior to the index procedure\n19. Active infection not controlled with antibiotic therapy\n20. Suspected or known pregnancy. Women of child-bearing age should have a negative pregnancy test.\n21. Body mass index (BMI) over 40 kg\u002Fm2\n22. Unable or unwilling to undergo screening, device implant and retrieval procedures, and 30-day follow-up\n23. Currently participating in an investigational drug or another device study that may influence the data collected for this study. Observational studies are not considered an exclusion\n24. Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject ability to give written informed consent and\u002For to comply with study procedures\n25. Active SARS-CoV-2 infection (Coronavirus-19 \\[COVID-19\\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments",{"count":253,"type":21},5,[24],"Evaluation of the safety and efficacy of the ModulHeart System in patients hospitalized with acute decompensated heart failure (ADHF) and diuretic resistance",[60,205,28,66,257,258,259],"Heart Failure With Preserved Ejection Fraction","Heart Failure With Reduced Ejection Fraction","Diuretic Resistance",[261,262,263,264,265,101,266,267,268],"Puzzle Medical Devices","ModulHeart","Mechanical Circulatory Support","Intra-Aortic","MCS","pVAD","percutaneous ventricular assist device","Left ventricular assist device","2024-06-13",{"date":271,"type":37},"2024-06-17",{"date":273,"type":21},"2024-08",{"date":275,"type":21},"2024-12",{"name":277,"class":80},"Puzzle Medical Devices Inc."]