[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-failure-congestive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-failure-congestive":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,76,107,145,181],{"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":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100071318","magnetic-resonance-spectroscopy-studies-of-cardiac-muscle-metabolism-100071318","NCT00181259","Magnetic Resonance Spectroscopy Studies of Cardiac Muscle Metabolism","In Vivo Cardiac Metabolism in Normal, Ischemic, and Cardiomyopathic Patients During Rest and Stress","Inclusion Criteria:\n\n* age \\> 18 years\n* Healthy subjects: no history of heart disease\n* Dilated cardiomyopathy: history of heart failure, ejection fraction (EF) \\\u003C40%\n* Left ventricular hypertrophy: wall thickness \\>1.2cm\n* Coronary artery disease: \\>50% coronary lesion or positive stress test\n\nExclusion Criteria:\n\n* contraindication to MRI",true,"18 Years",{"count":61,"type":21},500,"OBSERVATIONAL","The metabolism of the heart provides the chemical energy needed to fuel ongoing normal heart contraction. Magnetic resonance spectroscopy is a technique used in a MRI scanner that can be used to measure and study heart metabolism directly but without blood sampling or obtaining tissue biopsies. One of the hypotheses this study aims to investigate is whether energy metabolism is reduced in heart failure and whether that contributes to the poor heart function.",[34],"2026-03-06",{"date":67,"type":42},"2026-03-09",{"date":69,"type":4},"1988-01",{"date":71,"type":21},"2028-08",{"name":73,"class":74},"Johns Hopkins University","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100112813","prospective-observational-study-of-the-icd-in-sudden-cardiac-death-prevention-100112813","NCT00733590","Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention","Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)","PROSe-ICD","Inclusion Criteria:\n\n* History of acute MI at least 4 weeks old\n* Non-ischemic LV dysfunction for at least 9 months\n* Who have an ejection fraction (EF) \\\u003C or = to 35%\n* Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.\n* Who have primary prevention implants.\n\nExclusion Criteria:\n\n* ICD generator replacement for secondary prevention\n* Inability or unwillingness to provide valid informed consent\n* New York Heart Association Class IV heart failure\n* Patients with pre-existing Class 1 indications for pacemaker therapy.","85 Years",{"count":86,"type":21},1500,"The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to :\n\n1. to gain a better understanding of the biological mechanisms that predispose to SCD\n2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly",[34,89,90,91],"Death, Sudden, Cardiac","Arrhythmia","Cardiomyopathies",[93,94,95,96,97],"defibrillator, implanted","genomics","electrocardiography","electrophysiological study","proteomics","2026-01-15",{"date":100,"type":42},"2026-01-20",{"date":102,"type":42},"2003-06",{"date":104,"type":21},"2029-03",{"name":73,"class":74},4,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":84,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":126,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":75},"100600620","phase-4-effect-of-losartan-on-the-neurohumoral-axis-and-ventricular-remodeling-of-patients-with-severe-aortic-regurgitation-undergoing-valve-surgery-100600620","NCT07099859","Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery.","Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Undergoing Valve Surgery","ARBNP","Inclusion criteria:\n\n* Age ≥ 18 years;\n* Postoperative period of aortic valve replacement surgery due to severe aortic regurgitation of any etiology;\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\nTo avoid potential bias in data interpretation, the following patients will be excluded:\n\n* Those who underwent cardiac surgery in the context of cardiogenic shock or infective endocarditis;\n* Patients with ischemic cardiomyopathy;\n* Patients with other significant concomitant valvular diseases.\n\nPatients with conditions where losartan use may be harmful will also be excluded, including:\n\n* Chronic kidney disease with an estimated glomerular filtration rate (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m²);\n* Systolic blood pressure (SBP) \\\u003C 90 mmHg at the time of randomization;\n* Elevated serum potassium (K \\> 5.5 mEq\u002FL) at the time of randomization;\n* Pregnancy;\n* Known intolerance or allergy to losartan.",{"count":116,"type":21},60,[118],"PHASE4","Why Is This Study Important? The heart has valves that help control blood flow. Aortic regurgitation (AR) is a condition where one of these valves (the aortic valve) doesn't close properly, causing blood to leak back into the heart. Over time, this makes the heart work harder and grow larger (remodeling) to keep up. Many patients with severe AR need valve replacement surgery to fix this problem.\n\nAfter surgery, the heart doesn't have to work as hard, and over time, it can shrink back to a healthier size (reverse remodeling). However, doctors don't know if medications can help speed up or improve this healing process. This study aims to find out if a common blood pressure medication, losartan, can help the heart recover better after surgery.\n\nWhat Do the Investigators Already Know? Doctors often prescribe medications like ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and spironolactone to people with heart failure because these drugs help the heart function better and prevent worsening disease. However, these medications haven't been studied in people with valve disease because most major research studies excluded patients with valve problems.\n\nEven though there is not strong evidence, many doctors prescribe these medications after valve surgery, assuming they might be helpful. But is that really the case? That's the question this study hopes to answer.\n\nWhat Is This Study About?\n\nThis study will test whether losartan, a medication often used for high blood pressure, can help hearts recover better after aortic valve replacement surgery. The researchers will compare two groups of patients:\n\n* One group will take losartan (50 mg per day) after surgery.\n* The other group will take a placebo (a pill with no active medication).\n\nBy comparing these two groups, the study will determine whether losartan helps the heart shrink back to a normal size faster and function better after surgery.\n\nHow Will the Study Work? Who? 60 patients with severe AR who are having aortic valve replacement surgery.\n\nHow? Patients will be randomly placed into one of the two groups (losartan or placebo).\n\nFor how long? Patients will be followed for one year after surgery. What Will Be Measured?\n\nDoctors will check patients four times: before surgery, and 1 month, 3 months, and 12 months after surgery. At each visit, the investigators will measure:\n\n* NT-proBNP levels: A blood test that tells us how much strain the heart is under. Lower levels mean the heart is recovering well.\n* Echocardiogram: An ultrasound of the heart to check its size and function.\n* 6-minute walk test: To see if patients feel stronger and can exercise better.\n* Quality of life survey: To understand how patients feel physically and emotionally.\n* Kidney function and electrolyte levels: To check for medication side effects.\n\nWhy Is This Study Exciting? This is the first study to test whether a medication can help the heart heal better after valve surgery. If losartan proves beneficial, it could change how doctors treat patients after surgery and lead to better recovery, stronger hearts, and healthier lives.\n\nMany people with aortic regurgitation have to wait until their symptoms get worse before patients can have surgery. If this study finds that medication can speed up healing, it could help doctors treat valve disease more effectively and improve long-term outcomes for patients.\n\nWhat Happens Next? If losartan is found to be helpful, this study could lead to larger research trials and, eventually, new treatment guidelines for people who have had aortic valve surgery. If it doesn't help, doctors will know not to prescribe it unnecessarily, preventing unnecessary side effects and costs for patients. Either way, the results will help improve care for people with heart valve disease.\n\nBy participating in this study, patients are helping researchers discover new ways to improve heart health and recovery after surgery.",[121,122,123,124,125],"Heart Valve Diseases","Left Ventricle Remodeling","Aortic Regurgitation Disease","Heart Failure Congestive","Natriuretic Peptide, Brain",[127,128,129,130,131,132,133,134,135],"aortic regurgitation","valve disease","heart surgery","heart failure","losartan","Brain natriuretic peptide - BNP","biomarkers","renin-angiotensin-aldosterone system","neurohumoral axis","2025-07-29",{"date":138,"type":42},"2025-08-01",{"date":140,"type":42},"2025-07-01",{"date":142,"type":21},"2029-07-01",{"name":144,"class":74},"Vitor Emer Egypto Rosa",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":161,"overallStatus":171,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":153},"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":153,"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",[27,157,28,34,158,159,160],"Acute Decompensated Heart Failure","Heart Failure With Preserved Ejection Fraction","Heart Failure With Reduced Ejection Fraction","Diuretic Resistance",[162,163,164,165,166,167,168,169,170],"Puzzle Medical Devices","ModulHeart","Mechanical Circulatory Support","Intra-Aortic","MCS","LVAD","pVAD","percutaneous ventricular assist device","Left ventricular assist device","NOT_YET_RECRUITING","2024-06-13",{"date":174,"type":42},"2024-06-17",{"date":176,"type":21},"2024-08",{"date":178,"type":21},"2024-12",{"name":180,"class":49},"Puzzle Medical Devices Inc.",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":75},"100532852","phase-4-diuretics-vs-afterload-reduction-for-treatment-of-heartlogic-alerts-100532852","NCT06218199","Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts","Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)","DART-HA","Inclusion Criteria:\n\n* Boston Scientific device with HeartLogic enabled\n* Lack of standard contraindications to Sacubitril\u002Fvalsartan:\n\n  * history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema.\n  * hypotension, hypovolemia\n  * renal artery stenosis, renal failure\n  * hyperkalemia\n  * hepatic disease Child-Pugh class C\n  * Pregnancy\u002FBreast-feeding\n* Lack of standard contraindications to diuretic therapy\n* Systolic Blood Pressure \\> 105\n\nExclusion Criteria:\n\n* Glomerular filtration rate \\\u003C25 mL\u002Fmin who are non-responsive to diuretic therapy or are on chronic renal dialysis\n* ongoing symptoms of heart failure decompensation (increased dyspnea and\u002For fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ).\n* recent significant change in arrhythmia burden (within the past 2 weeks)\n* in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %)\n* the subject is unable to sign or refuses to sign the patient informed consent\n* Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment\n* the subject is implanted with unipolar right atrial or right ventricular leads\n* subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months\n* subject is pregnant or planning to become pregnant during the study\n* regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)","19 Years",{"count":191,"type":21},80,[118],"The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.",[34],"2024-01-25",{"date":197,"type":42},"2024-01-29",{"date":199,"type":42},"2021-07-08",{"date":201,"type":21},"2026-12-31",{"name":203,"class":204},"Heart Center Research, LLC","NETWORK"]