[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardio-renal-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardio-renal-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,78,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100491282","diuretics-alone-vs-aortix-endovascular-device-for-acute-heart-failure-100491282",false,"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.","ALL","21 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34],"Heart Failure","Cardiorenal Syndrome","Cardio-Renal Syndrome","ADHF","Heart Failure, Systolic","Heart Failure, Diastolic","Heart Failure; With Decompensation","Heart Failure, Congestive",[36,37],"mechanical circulatory support","percutaneous","RECRUITING","2026-06-05",{"date":41,"type":42},"2026-06-09","ACTUAL",{"date":44,"type":42},"2023-08-23",{"date":46,"type":21},"2027-08",{"name":48,"class":49},"Procyrion","INDUSTRY",48,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100628627","evaluation-of-the-impact-of-interventional-treatments-for-symptomatic-severe-tricuspid-valve-insufficiency-on-renal-integrity-and-function-as-well-as-on-physical-function-and-activity-in-older-adults-100628627","NCT07464106","Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.","TriRenGe","Inclusion Criteria:\n\n* Severe symptomatic tricuspid valve insufficiency and referral for TriClip\u002FTricValve screening\n* Completed 18th year of life\n* Ability to consent\n* Able to walk short distances with aids\n\nExclusion Criteria:\n\n* Dialysis-dependent\u002Fterminal kidney disease\n* Inability to comply with study-associated assessments (e.g., existing dementia)\n* Severe anemia (Hb \\\u003C7 g\u002Fdl)\n* Tricuspid valve intervention with palliative intent and likely imminent death\n* Lack of consent","18 Years",{"count":60,"type":21},100,"OBSERVATIONAL","The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.",[64,65,29,66],"Tricuspid Regurgitation","Tricuspid Valve Insufficiency","Frailty","2026-03-09",{"date":69,"type":42},"2026-03-11",{"date":71,"type":42},"2025-02-01",{"date":73,"type":21},"2027-12",{"name":75,"class":76},"Robert Bosch Medical Center","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":61,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":77},"100556185","cardio-renal-registry-100556185","NCT06521801","Cardio-Renal Registry","Barts Health Cardio-Renal Registry","BHCRR","Informed consent will not be sought for, as patients are automatically included onto a database that we will use for research purposes. No children will be included in this study. Vulnerable adults or those unable to give consent will be included in the study as well if they are referred to the Nephrology team.\n\nInclusion Criteria:\n\n1. Both male and female patients ≥16 years of age will be included\n2. All patients will be reviewed by the Nephrology team a the RLH with renal disease.\n\nExclusion Criteria:\n\n1\\. Patients \\\u003C16 years will not be included in this study.","16 Years",{"count":88,"type":21},60000,"12 Weeks","Cardiovascular disease is the leading cause of morbidity and mortality among patients with chronic kidney disease (CKD). Even after adjustment for known cardiovascular risk factors, including diabetes and hypertension, mortality risk progressively increases with worsening CKD. As glomerular filtration rate (GFR) declines the probability of developing coronary artery disease (CAD) increases linearly, and patients with GFR \\\u003C60 mL\u002Fmin\u002F1.73 m2 have 2-3-fold increased CV mortality risk, relative to patients without CKD. Management of CAD is complicated in CKD patients due to the likelihood of comorbid conditions and potential for side effects. Despite their high cardiovascular risk, ACS patients with renal dysfunction are less commonly treated with guideline-based medical therapy and are less frequently referred for coronary revascularisation. This observation, referred to as the \"treatment risk paradox,\" has been well described and may be explained by physicians' concerns regarding possible nonrenal side effects as well as renal toxicities. Furthermore, patients with severe CKD have traditionally been under-represented in most large cardiovascular clinical trials. Therefore, recommendations for both medical and revascularisation of CAD have relied heavily on extrapolation of results from the non-CKD population.\n\nThis data will add to that literature by assessing the characteristics and outcomes of patients with CAD and CKD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.",[92,29,93,94,95,96],"End Stage Renal Disease","Myocardial Infarction","Cerebrovascular Accident","Percutaneous Coronary Intervention","Dialysis","2026-01-05",{"date":99,"type":42},"2026-01-07",{"date":101,"type":42},"2024-08-01",{"date":103,"type":21},"2030-06-01",{"name":105,"class":76},"Queen Mary University of London",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100593586","phase-3-the-role-of-intraabdominal-pressure-and-point-of-care-ultrasound-to-guide-decongestive-therapy-in-heart-failure-100593586","NCT07008365","The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure","ABDOPOCUS-HF","Inclusion Criteria:\n\n* Men or women over 18 years of age.\n* Diagnosis of heart failure (HF) based on the latest HF guidelines published in 2022.\n* N-terminal pro b-type natriuretic peptide (NT-proBNP) \\> 1000 pg\u002FmL or Brain Natriuretic Peptide (BNP) \\> 250 pg\u002FmL.\n* Placement of a urinary catheter to allow for the measurement of intra-abdominal pressure.\n* Intravascular or mixed congestion pattern, defined as the presence of one or more clinical signs of congestion (edema, ascites, and\u002For pleural effusion).\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient with a stay in the Internal Medicine department \\> 24 hours.\n* Absence of sufficient clinical congestion (ADVOR score = 0 at the time of randomization).\n* Patient\\'s refusal to participate in the clinical trial.\n* Inability or contraindication for urinary catheter placement.\n* Systolic blood pressure at admission \\< 100 mmHg.\n* Heart rate at admission \\> 170 beats per minute (bpm).\n* Cardiogenic shock.\n* Acute myocardial ischemia.\n* Patients receiving renal replacement therapy (ultrafiltration or peritoneal dialysis).\n* Kidney transplant recipients.\n* Serum hemoglobin \\< 9 g\u002FdL.\n* Pregnancy or breastfeeding.\n* History of hypersensitivity to hydrochlorothiazide or furosemide.\n* Patients admitted from the Intensive Care Unit.\n* Patients with recent cardiac surgery (within the last year) or heart transplant recipients.\n* Need for inotropic support to maintain adequate cardiac and\u002For renal output.","100 Years",{"count":115,"type":21},168,[117],"PHASE3","Systemic venous congestion is the primary therapeutic target of intravenous loop diuretics in patients admitted for acute heart failure (AHF). Despite their utility, a significant proportion of AHF patients are discharged with persistent clinical symptoms of congestion (residual congestion). Therefore, in recent years, there has been a growing focus on the use of tools (biomarkers, clinical ultrasound) that allow us to optimize diuretic treatment and thereby improve the prognosis of AHF patients. The objective is to analyze whether the strategy of guiding intravenous loop diuretic dosing based on intra-abdominal pressure(IAP) measurements and clinical ultrasound is superior to the conventional strategy employed in daily clinical practice. This study is a randomized, multicenter clinical trial involving consecutive patients admitted with a diagnosis of AHF in the Internal Medicine and Cardiology departments. Patients who meet the inclusion criteria, after signing informed consent, will be randomized into two groups: 1) Diuretic treatment guided by usual clinical practice and 2) Treatment guided by intra-abdominal pressure levels and clinical ultrasound (inferior vena cava and portal Doppler). This strategy will be maintained during the first 72 hours of admission, with a thorough analysis of congestion and diuretic response being conducted.",[120,121,122,29],"Acute Heart Failure","Congestive Heart Failure","Intraabdominal Hypertension",[124,120,125,126,127],"Point of care Ultrasound (POCUS)","Cardio-renal syndrome","Intraabdominal pressure","Diuretic treatment","2025-06-04",{"date":130,"type":42},"2025-06-06",{"date":132,"type":42},"2025-03-10",{"date":134,"type":21},"2026-12-31",{"name":136,"class":76},"Instituto de Investigación Sanitaria Aragón",2]