[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"left-ventricular-assist-device\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:left-ventricular-assist-device":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,87,116,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644191","phase-1-a-study-of-metformin-to-improve-cardiac-function-after-lvad-implantation-100644191",false,"NCT07666698","A Study of Metformin to Improve Cardiac Function After LVAD Implantation","Study on the Effect of Metformin in Improving Cardiac Function After Implantation of Left Ventricular Assist Devices","Inclusion Criteria:\n\n* Age 18-75 years\n* Receiving continuous-flow LVADs, such as HeartMate 3, HVAD, Core-Heart 6, Brio-Heart\n* Presence of insulin resistance\n* HbA1c ≤ 6.5%\n\nExclusion Criteria:\n\n* Diagnosed type 1 diabetes mellitus, or type 2 diabetes mellitus with HbA1c \\> 6.5% (patients with prior type 2 diabetes who are currently off therapy and have HbA1c ≤ 6.5% may be enrolled; such patients may still have insulin resistance but have achieved glycemic control)\n* History of diagnosed diabetic ketoacidosis or hyperosmolar hyperglycemic state\n* Currently using any glucose-lowering medications (including insulin, oral hypoglycemic agents, GLP-1 receptor agonists, SGLT2 inhibitors, etc.)\n* History of diagnosed polycystic ovary syndrome (PCOS) and currently undergoing treatment\n* Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation)\n* History of acute kidney injury (KDIGO criteria) with incomplete renal recovery\n* Receiving any form of renal replacement therapy (hemodialysis, peritoneal dialysis)\n* Post-kidney transplantation or awaiting kidney transplantation\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3× the upper limit of normal, total bilirubin \\> 2× upper limit of normal, or Child-Pugh class B or C cirrhosis\n* Active viral hepatitis\n* History of alcoholic liver disease or drug-induced liver injury currently in the active phase\n* Concurrent right ventricular assist device (RVAD) or total artificial heart implantation\n* LVAD-related complications requiring surgical intervention within 30 days postoperatively, including but not limited to: pump thrombosis requiring LVAD exchange or thrombolysis, driveline infection requiring debridement or replacement, hemorrhagic complications requiring re-sternotomy, device malfunction requiring urgent intervention\n* Acute kidney injury requiring ongoing renal replacement therapy (CRRT) within 30 days postoperatively\n* Preoperative severe right heart failure (on echocardiography: right ventricular fractional area change \\\u003C 35%, or tricuspid annular plane systolic excursion \\\u003C 14 mm; or right heart catheterization showing central venous pressure \\> 15 mmHg and cardiac index \\\u003C 2.0 L\u002Fmin\u002Fm²)\n* Preoperative severe pulmonary arterial hypertension (mean pulmonary arterial pressure ≥ 40 mmHg and pulmonary vascular resistance ≥ 4 Wood units)\n* Within 30 days postoperatively, occurrence of severe low cardiac output syndrome requiring extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) support\n* Significant prosthetic valve dysfunction or severe prosthetic valve infectious endocarditis\n* Severe unrepaired valvular disease\n* Active systemic infection or sepsis requiring ongoing intravenous antibiotics or antifungal therapy\n* Active infectious endocarditis (modified Duke criteria) or high clinical suspicion\n* Human immunodeficiency virus (HIV) infection with CD4 count \\\u003C 200\u002FμL or not on regular antiretroviral therapy\n* Active tuberculosis or non-tuberculous mycobacterial infection\n* Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection\n* Known active inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease) currently requiring immunosuppressive therapy\n* Platelet count \\\u003C 50 × 10⁹\u002FL, hemoglobin \\\u003C 80 g\u002FL, international normalized ratio (INR) \\> 3.0 and not reversible (unless on warfarin with INR within the target range)\n* Known bleeding disorders (e.g., hemophilia, von Willebrand disease, acquired von Willebrand syndrome)\n* Malignancy diagnosed within the past 5 years (except for cured thyroid cancer, breast cancer, lung cancer, cervical cancer, etc.) and currently receiving chemotherapy, radiotherapy, or targeted therapy\n* Prior recipients of heart transplantation or other organ transplants\n* Patients awaiting heart transplantation with an anticipated waiting time of less than 3 months\n* Pregnant or lactating women\n* Reproductive-age women who are capable of conceiving but refuse to use effective contraception during the study period (including surgical sterilization, intrauterine device, oral contraceptives, condoms, etc.)\n* Women planning pregnancy during the study\n* Known allergy to metformin or any drug excipient\n* Known history of lactic acidosis\n* Currently using medications that may significantly increase the risk of lactic acidosis, including but not limited to: carbonic anhydrase inhibitors (topiramate, acetazolamide), antiretroviral drugs (especially nucleoside reverse transcriptase inhibitors), certain chemotherapeutic agents (cisplatin)\n* Currently using medications that may affect glycemic control or insulin sensitivity and that cannot be stopped or substituted during the study, including but not limited to: systemic glucocorticoids (prednisone-equivalent dose \\> 10 mg\u002Fday for \\> 2 weeks), high-dose thiazide diuretics (hydrochlorothiazide \\> 50 mg\u002Fday), atypical antipsychotics (olanzapine, clozapine, etc.), immunosuppressants (tacrolimus, cyclosporine, etc.)\n* Unable to complete 12-month follow-up\n* Known psychiatric disorders or cognitive impairment that may affect informed consent validity or study compliance\n* History of drug or alcohol abuse (within the past year)\n* Concurrent participation in another clinical trial\n* Any other circumstance, as determined by the investigator, that would render the subject unsuitable for enrollment (including but not limited to social, psychological, or geographic factors)","ALL","18 Years","75 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study investigates whether metformin, compared with placebo, improves cardiac function in patients after Left Ventricular Assist Device (LVAD) implantation. Metformin is a widely used oral medication for type 2 diabetes, but emerging evidence suggests it may have beneficial effects on cardiac metabolism and function independent of its glucose-lowering effects. This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 108patients undergoing LVAD implantation will be enrolled from 5 centers in China. Eligible participants will be randomly assigned in a 1:1 ratio to receive either metformin or placebo for 12 months.\n\nThe primary outcome is the incidence of Full Responder at 12 months post-implantation. A Full Responder is defined as meeting all of the following four criteria: (1) left ventricular ejection fraction (LVEF) ≥40% and left ventricular end-diastolic diameter (LVEDD) ≤6.0 cm (Utah-Inova Responder criteria); (2) soluble ST2 (sST2) ≤100 ng\u002FmL at both 6 months and 12 months post-implantation; (3) absolute value of left ventricular global longitudinal strain (GLS) ≥12% at 12 months post-implantation.\n\nSecondary outcomes include clinical events, cardiac function status, blood biomarker results, global functional status and quality of life, medication safety, and exploratory measures. Clinical events assessed up to 24 months post-implantation include: heart failure rehospitalization rate, all-cause mortality, LVAD explantation rate, cardiovascular mortality, major bleeding, cardiac structural damage, thromboembolic events, systemic inflammatory dissemination, sepsis, and other serious adverse events.\n\nCardiac function status is evaluated by echocardiographic parameters (LVEF, LVEDD, GLS) and hemodynamic measures. Blood biomarkers include sST2, NT-proBNP, cardiac troponin, and inflammatory cytokines. Global functional status and quality of life are measured using the 6-minute walk test (6MWT), peak oxygen consumption (VO₂max), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). Safety outcomes include the incidence and severity of adverse events, serious adverse events, and adverse events of special interest. Exploratory outcomes include pre-implantation right ventricular myocardial biopsy (obtained only when clinically indicated for temporary pacemaker lead placement) to assess insulin receptor substrate (IRS)\u002FAkt phosphorylation, G6PD activity, NADPH\u002FNADP⁺ ratio, and oxidative stress markers (malondialdehyde, 4-hydroxynonenal).\n\nThe study aims to provide evidence on whether adjunctive metformin therapy can improve post-LVAD cardiac outcomes and reduce adverse clinical events.",[28,29],"Heart Failure","Left Ventricular Assist Device",[31,32,33,34,35],"Metformin","Cardiac Function","LVAD","Randomized Controlled Trial","Full Responder","NOT_YET_RECRUITING","2026-06-18",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":21},"2026-07",{"date":44,"type":21},"2029-09",{"name":46,"class":47},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":74,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100640479","reaction-vad-trial-remote-exercise-training-via-telemedicine-in-patients-with-long-term-ventricular-assist-devices-100640479","NCT07611188","REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices","Efficacy and Safety of a Remote Conditioning Program in Patients Supported With a Ventricular Assist Device: THE RE-ACTION-VAD TRIAL.","REACTION-VAD","Inclusion Criteria (must meet all):\n\n* Recent LVAD Implantation (\\\u003C6 months)\n* Clinical stability (defined as meeting all of the following criteria): discharge from the LVAD implantation hospitalization, absence of inotropic medication, hemoglobin \\>9 g\u002FdL, and no active infection.\n* Inability to participate in a supervised rehabilitation program (due to lack of availability, or inability because geographical reasons).\n\nExclusion Criteria (any):\n\n* Functional Inability to Perform Cardiopulmonary Exercise Testing\n* Prior Participation in a Supervised Rehabilitation Program (after the LVAD implantation)",{"count":58,"type":21},78,[60],"NA","Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis.\n\nThe goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity.\n\nThe trial aims to answer the following questions:\n\n* Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test.\n* Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch?\n* Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire.\n\nResearchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily.\n\nParticipants will:\n\n* Join the study voluntarily after signing a consent form.\n* Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery.\n* Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring.\n* Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.",[28,63,29,33,64,65,66,67,68,69,70,71,72,73],"Advanced Heart Failure","Cardiac Rehabilitation","Telemedicine","Remote Exercise","Ventricular Assist Device","Exercise Training","Conditioning Therapy","Cardiopulmonary Exercise Test","Six Minute Walk Test","Quality of Life","Telerehabilitation",[29,63,28,64,75,65,76,72,70,73],"Remote rehabilitation","6 minute walking test","2026-05-20",{"date":79,"type":40},"2026-05-28",{"date":81,"type":21},"2026-05",{"date":83,"type":21},"2030-12",{"name":85,"class":47},"Puerta de Hierro University Hospital",10,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100627230","palliative-care-intervention-to-improve-health-related-quality-of-life-for-patients-on-long-term-lvad-support-100627230","NCT07445932","Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support","The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial","PALL-VAD","Inclusion Criteria:\n\n* LVAD patients \\>= 18 years of age\n* \\>= 1 year post-LVAD implantation\n\nExclusion Criteria:\n\n* Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.\n* Non-English speaking\n* Receiving outpatient palliative care in the last 6 months\n* Renal replacement therapy\n* Non-cardiac terminal illness\n* Women who are pregnant or planning to become pregnant\n* Inability to comply with study protocol and follow up\n* Inabilty to provide consent.\n* Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.",{"count":96,"type":21},90,[60],"Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care.\n\nProblem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown.\n\nObjective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits.\n\nAims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population.\n\nSignificance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.",[63,100,29,101],"Mechanical Circulatory Support","Palliative Care",[103,104,105],"advanced heart failure","left ventricular assist device","palliative care","2026-02-25",{"date":108,"type":40},"2026-03-03",{"date":110,"type":21},"2026-03-01",{"date":112,"type":21},"2027-03-01",{"name":114,"class":47},"Medstar Health Research Institute",2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":48},"100558850","preventive-catheter-ablation-for-ventricular-arrhythmias-in-patients-with-end-stage-heart-failure-100558850","NCT06556485","Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure","Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)","CASTLE-VT","Inclusion Criteria:\n\n1. Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)\n2. Eligible for heart transplantation due to end-stage heart failure\n3. NYHA class ≥ III\n4. Impaired functional capacity or inability to exercise\n5. Indication for ICD therapy due to primary prevention\n6. Implanted ICD or ICD implantation within 3 months after randomization\n7. The patient is willing and able to comply with the protocol and has provided written informed consent\n8. Age ≥ 18 years\n\nExclusion Criteria:\n\n1. Previous catheter ablation for ventricular arrhythmias\n2. Previous appropriate ICD-therapy for ventricular arrhythmias\n3. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment\n4. Untreated hypothyroidism or hyperthyroidism\n5. Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age\n6. Mental or physical inability to participate in the study\n7. Listed as \"high urgent\" for heart transplantation\n8. Cardiac assist device implanted\n9. Planned cardiovascular intervention\n10. Life expectancy ≤ 12 month\n11. Uncontrolled hypertension\n12. Requirement for dialysis due to end-stage renal failure","99 Years",{"count":126,"type":21},160,[60],"CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia\u002Fventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.",[28,130,131,132,133,29],"Arrhythmia, Ventricular","Cardiomyopathy Ischemic","Catheter Ablation","Heart Transplantation","RECRUITING","2024-12-01",{"date":137,"type":40},"2024-12-04",{"date":139,"type":40},"2024-09-13",{"date":141,"type":21},"2027-01-01",{"name":143,"class":47},"Heart and Diabetes Center North-Rhine Westfalia",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":153,"studyType":154,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":134,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":48},"100391505","prognostic-value-of-bnp-in-mcs---a-25-year-follow-up-study-100391505","NCT04377854","Prognostic Value of BNP in MCS - a 25 Year Follow up Study","The Prognostic Value of proBNP in Patients Supported With Durable Mechanical Circulatory Assist Devices - a 25 Year Follow up Study.","Inclusion Criteria:\n\n* All patients referred for evaluation for advanced HF treatment at the Rigshospital in Denmark\n* Age\\>18 years\n\nExclusion Criteria:\n\n* No consent",{"count":152,"type":21},1000,"25 Years","OBSERVATIONAL","A biobank has been created to investigate the prognostic value of biomarkers (mainly BNP) in patients implanted with durable mechanical assist devices comparing patients with advanced HF supported by MCS with those who are transplanted and those who remain on optimal medical therapy.\n\nPatients will be followed up for 25 years after inclusion.",[28,29,157,158],"Prognosis","Durable Mechanical Support Device","2021-04-29",{"date":161,"type":40},"2021-05-05",{"date":163,"type":40},"2020-09-18",{"date":165,"type":21},"2045-08-01",{"name":167,"class":47},"Rigshospitalet, Denmark"]