[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transplant-failure-heart\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transplant-failure-heart":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,72,93,112],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100584877","xvivo-heart-box-xhb-with-supplemented-xvivo-heart-solution-sxhs-continued-access-protocol-cap-100584877",false,"NCT06895070","XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP)","PRESERVE CAP: A Prospective, Multi-Center, Single-Arm, Open-Label Study of Hearts Transplanted After Non-Ischemic Heart Preservation From Extended Donors Continued Access Protocol","NIHP-CAP-001","Inclusion Criteria Recipient:\n\nTo be eligible to participate in this study, a recipient must meet all the following criteria:\n\n1. Age ³18 years.\n2. Signed informed consent form (ICF).\n3. Listed for heart transplantation.\n\nExclusion Criteria Recipient:\n\n1. Previous solid organ or bone marrow transplantation.\n2. Requires a multi-organ transplant.\n3. Subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (Exception: observational studies are permitted).\n4. Subject is on mechanical circulatory support pre-transplant other than durable LVAD, Impella or intra-aortic balloon pump (IABP).\n5. History of complex congenital heart disease ie: single ventricle physiology (per Investigator's discretion and XVIVO review).\n6. Subject on renal replacement therapy\u002Fdialysis.\n7. Ventilator dependence (subject is intubated at time of transplant\u002Funable to provide consent or re-affirmation of consent).\n8. Sensitized participants meeting any of the following:\n\n   * Participant with calculated Panel Reactive Antibody (cPRA) greater than 50%\n   * Participant undergoing any desensitization treatment (also with cPRA less than 50%)\n   * Participant with a positive prospective crossmatch and\u002For a positive virtual cross match\n\nDonor Inclusion Criteria:\n\nTo be eligible to participate in this study, the donor heart must meet the following criteria:\n\n1. Estimated Cross Clamp Time ≥4 hours OR\n2. Estimated Cross Clamp ≥ 2 hours AND\n\nAny one or more of the following:\n\n* Age ≥50 years\n* LVEF 40% - 50% at time of provisional acceptance. (Refer to section 6.3.4 for definition of provisional acceptance).\n* Down-time ≥20 minutes\n* Hypertrophy septal thickness \\>12 - ≤16mm\n* Angiographic luminal irregularities with no significant CAD OR 1) Donation after Circulatory Death (DCD)\n\nDonor Exclusion Criteria:\n\nDonor hearts that meet any of the following criteria will be excluded from transplantation in this study:\n\n1. Unstable hemodynamics requiring high-dose inotropic support.\n2. Significantly abnormal coronary angiogram defined as CAD \\> 50% stenosis of one or more vessels or if the donor heart exhibits any contusions, structural damage, gross abnormalities, or palpable CAD on final examination.\n3. Moderate to severe cardiac valve pathology.\n4. Investigator's clinical decision to exclude from trial.\n5. Previous sternotomy.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate if Non-Ischemic Heart Preservation (NIHP) of extended criteria donor hearts using the XVIVO Heart Preservation System (XHPS) is a safe and effective way to preserve and transport hearts for transplantation.",[27,28,29],"Heart Transplant","Heart Failure","Transplant; Failure, Heart","RECRUITING","2026-03-16",{"date":33,"type":34},"2026-03-18","ACTUAL",{"date":36,"type":34},"2025-07-10",{"date":38,"type":21},"2031-05",{"name":40,"class":41},"XVIVO Perfusion","INDUSTRY",14,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100473983","hiit-in-pediatric-heart-transplant-recipients-medbike-100473983","NCT05451979","HIIT in Pediatric Heart Transplant Recipients (MedBIKE™)","High Intensity Interval Training in Pediatric Heart Transplant Recipients: Evaluating a Novel Telemedicine Video Game-Linked Exercise Platform (MedBIKE™)","Inclusion Criteria:\n\n* Pediatric heart transplant recipients, at least 6-months post heart transplantation\n* Aged 10-18 years\n\nExclusion Criteria:\n\n* Non-English speaking (thus limiting communication during the MedBIKE™ sessions)\n* Home environment cannot accommodate the MedBIKE™ system (for example, space limitations)\n* History of multiorgan transplant\n* Adult unavailable to supervise the home-based exercise sessions\n* Episode of clinical antibody- or cellular-mediated rejection within 3-months of the baseline assessment\n* Previous involvement in a cardiac rehabilitation or exercise intervention program\n* Primary cardiologist has exercise restricted the participant or counsels against participation\n* Previous exercise stress test demonstrating sustained arrhythmias, ST segment elevation or depression greater than 3mm, an inappropriate rise in blood pressure (BP) (\\\u003C20 mmHg) or a systolic BP \\>200 mmHg, or symptoms of chest pain or syncope\n* Resting arterial saturation \\\u003C85% or oxygen requirements\n* Moderate ventricular systolic dysfunction (or worse) at the most recent echocardiogram\n* History of chest pain on exertion\n* Unrepaired\u002Funpalliated CHD\n* Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block (Mobitz II or worse))\n* New York Heart Association class II or worse symptoms\n* Active medical inter-current illness limiting ability to participate\n* Cognitive impairment limiting the communication needed for the HIIT program\n* Extracardiac or congenital abnormality limiting the participant's functional ability to exercise","10 Years",{"count":52,"type":21},10,[24],"Heart transplantation is the long-term treatment for children and adults with advanced heart failure. Post-transplant outcomes have improved over time, such that 50% of pediatric heart transplant recipients (HTR) remain alive with a need for re-transplantation 17-years following the initial transplant. With improved short- and medium-term outcomes, focus has shifted towards optimizing long-term survival and reducing transplant-associated morbidities. This includes strategies aimed at optimizing cardiorespiratory fitness and physical activity levels.\n\nPediatric and adult HTRs have reduced exercise capacity compared with the general population. Previous groups have shown gradual improvements in heart rate response to exercise and exercise capacity in pediatric HTRs. However, after an initial improvement, exercise capacity appears to plateau, or even decline in pediatric HTRs, and remains sub-optimal compared with the general population.\n\nMost exercise interventions in HTRs to date have focused on moderate-intensity continuous exercise (MICE), with some resistance components incorporated. More recently, high-intensity interval training (HIIT), consisting of short, intense bursts of exercise with rest periods, has been explored in the adult HTR population, with findings to date suggesting that it may yield greater improvements in cardiorespiratory fitness compared with MICE. Exercise interventions, particularly HIIT interventions, have consistently shown clinically important improvements in exercise capacity in adult HTRs that are linked with improved long-term post-transplant outcomes and well-being. Unfortunately, trials of exercise interventions in pediatric HTRs remain lacking. This study team is proposing an assessment of the feasibility of a home-based HIIT exercise program using a novel telemedicine-enable video game linked customizable cycle ergometer (MedBIKE™).",[56,29],"Pediatric ALL",[58,59,60],"Cardiac rehabilitation","High Intensity Interval Training","Telemedicine","2026-03-11",{"date":63,"type":34},"2026-03-13",{"date":65,"type":34},"2022-02-22",{"date":67,"type":21},"2027-12-31",{"name":69,"class":70},"University of Alberta","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":71},"100412863","cardiopulmonary-stress-testing-cpet-allosure-study-100412863","NCT04656080","Cardiopulmonary Stress Testing (CPET) AlloSure Study","AlloSure Test Characteristics in Immunologically Quiescent and Immunologically Active Heart Transplant Recipients: Does Maximal Cardiopulmonary Stress Testing Prior to Assay Preserve Test Specificity While Enhancing Sensitivity?","Inclusion Criteria:\n\nPost-orthotopic heart transplant patients\n\nExclusion Criteria:\n\n1. orthopedic, neurologic and\u002For any other limitations that do not allow for exercise testing on a treadmill or cycle ergometer;\n2. individuals who require supplemental oxygen or have current permanent tracheostomies will be excluded from this study;\n3. individuals who are discharged to a long-term acute care facility;\n4. skilled nursing facility or with palliative care or hospice care will be excluded; (e) inmates and pregnant women;\n\n(f) patients with antibody-mediate rejection that are not felt to be safe for cardiopulmonary stress testing.",{"count":80,"type":21},27,"OBSERVATIONAL","1. Cell-free DNA does not vary significantly as a function of the activity of immunologically quiescent cardiac transplant recipients, despite the metabolic demands of the transplanted organ. (The implication of the null result would be that no restrictions to patient activity, nor modification of cardiac rehabilitation prescription, would be necessary to maintain proper test characteristics of AlloSure testing).\n2. In immunologically active cardiac transplant allografts, exercise prior to assay of donor-derived cell-free DNA can be used to increase the sensitivity of the AlloSure test. (The implication of this would be that the optimal time-frame for drawing an Allosure may actually be post-exercise, and that window will be characterized).",[28,29],"2026-01-20",{"date":86,"type":34},"2026-01-22",{"date":88,"type":34},"2020-05-21",{"date":90,"type":21},"2027-12",{"name":92,"class":70},"Baylor Research Institute",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":71},"100400373","the-hepatitis-c-transplant-collaborative-100400373","NCT04493385","The Hepatitis C Transplant Collaborative","Nationwide Hepatitis C NAT+ Cardiac Transplant Experience","Inclusion Criteria:\n\n1. Recipient of a proven HCV NAT+ donor heart.\n2. Re-transplant patients will be included.\n\nExclusion Criteria:\n\n1\\. Multi-organ transplantation",true,{"count":102,"type":21},500,"In this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing HCV NAT+ donor organs as currently performed are acceptable.",[29,105],"Hepatitis C",{"date":86,"type":34},{"date":108,"type":34},"2019-09-16",{"date":110,"type":21},"2030-12",{"name":92,"class":70},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":71},"100546573","ease-sot-pilot-study-100546573","NCT06396702","EASE-SOT Pilot Study","Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study","Inclusion Criteria:\n\n* Participants consented pre-transplant: Potential transplant recipients who are listed on the waitlist and are identified by pre-transplant staff, recipients who have a living donor arranged (pertaining to kidney and liver recipients), participants currently completely pre-transplant prehabilitation (pertaining to lung and heart recipients), or those who are on the top of their respective organ transplant waitlists.\n* Participants consented post-transplant: Incident kidney, kidney-pancreas, liver, lung, or heart transplant recipients identified during index transplant hospital admission at the inpatient transplant unit of the Ajmera Transplant Centre at Toronto General Hospital\n\nExclusion Criteria:\n\n* Patients in ICU.\n* Patients who are clinically unstable, have delirium or other severe mental health concern requiring psychiatric treatment - assessed by clinical team.\n* Non-English speaking patients.\n* Severe cognitive impairment as assessed by the recruitment and\u002For research team. This will be determined through communication with the organ transplant teams and by checking the patient's medical charts. If no cognitive impairment is indicated by the patients organ transplant team or is documented in their medical chart, the patient will be assessed to have no cognitive impairment.\n* Unwilling or unable to provide informed consent.","19 Years",{"count":121,"type":21},120,[24],"Many transplant recipients may experience physical and emotional symptoms, such as anxiety, fatigue, sleep problems, pain, etc. Often, these symptoms are not reported or managed well, and can affect a patient's quality-of-life. Transplant recipients are grateful for the \"gift of life\" but physical and emotional symptoms reduce their quality-of-life. Transplant recipients and caregivers have felt unprepared for the ongoing symptoms and reduced quality-of-life post-transplant.\n\nOne way of monitoring and managing these symptoms is using the Emotion And Symptom-focused Engagement (EASE) intervention. EASE was originally developed for patients with acute leukemia and has begun to be adapted to help monitor and manage physical and emotional symptoms for organ transplant recipients.\n\nEASE is comprised of two components:\n\n1. Psychological - 8 supportive counselling sessions delivered by mental health clinicians to address concerns about mental health, losses from organ failure, coping with a transplant, experiences with living on the brink of death for a prolonged period of time, etc.\n2. Physical - Regular assessments of physical symptoms using questionnaires and referral to healthcare professionals for symptom management as necessary.\n\nEASE uses questionnaires, also called patient reported outcome measures (PROMs), for symptom assessment and monitoring. PROMs measure symptom severity, similarly to how bloodwork measures organ functioning. PROMs, as part of EASE, will ask recipients questions and help identify relevant physical, emotional, and social symptoms to enhance their care.\n\nWith the help of specialists, patients, and support from the Kidney Foundation of Canada, our team has begun to adapt the EASE intervention for transplant recipients. In order to finalize the adaptation of the EASE intervention for use in a routine transplant clinic, we are launching a pre-pilot study to gain real-life experience from managing symptoms of SOT recipients with the use of EASE-SOT.",[125,29,126,127,128],"Transplant;Failure,Kidney","Transplant; Failure, Liver","Transplant; Failure, Pancreas","Transplant; Failure, Lung(S)","NOT_YET_RECRUITING","2024-04-29",{"date":132,"type":34},"2024-05-02",{"date":134,"type":21},"2024-05",{"date":136,"type":21},"2027-08",{"name":138,"class":70},"University Health Network, Toronto"]