[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-transplant-rejection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-transplant-rejection":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,67,99,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100416837","trifecta-heart-cfdna-mmdx-study-100416837",false,"NCT04707872","Trifecta-Heart cfDNA-MMDx Study","Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test","Inclusion Criteria:\n\n* All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study.\n* Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if they decline participation\n* Are unable to give informed consent.\n* Recipients of multiple organs.","ALL",{"count":18,"type":19},300,"ESTIMATED","OBSERVATIONAL","Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.",[23],"Heart Transplant Rejection",[25,26,27],"Donor derived cfDNA","gene expression","heart transplant biopsy","RECRUITING","2026-06-01",{"date":31,"type":32},"2026-06-02","ACTUAL",{"date":34,"type":32},"2021-06-01",{"date":36,"type":19},"2028-07",{"name":38,"class":39},"University of Alberta","OTHER",12,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100633830","a-national-swedish-study-evaluating-dd-cfdna-for-as-a-diagnostic-biomarker-for-rejection-surveillence-in-heart-transplantation-100633830","NCT07531784","A National Swedish Study Evaluating Dd-cfDNA for as a Diagnostic Biomarker for Rejection Surveillence in Heart Transplantation","A National Swedish Study Evaluating Donor-derived Cell-free DNA as a Diagnostic Biomarker in Heart Transplantation (SweD-HTx)","SweD-HTx","Inclusion Criteria:\n\n* Adults (≥18 years) who undergo orthotopic HTx.\n\nExclusion Criteria:\n\n* Pregnancy,\n* Multi-organ transplantation\n* Solid organ\n* Hematopoietic stem cell transplantation.","18 Years",{"count":51,"type":19},120,"The SweD-HTx-study is an observational, multicenter cohort study including adult HTx recipients from Skåne University Hospital (Lund), Sahlgrenska University Hospital (Gothenburg), and Karolinska University Hospital (Stockholm). The aim of the study is to establish a robust, nationwide protocol for dd-cfDNA-based rejection monitoring in Swedish HTx recipients and to enhance our understanding of rejection mechanisms and immune activation. All participants undergo endomyocardial biopsies as part of routine post-transplant surveillance. Heart transplantations are performed at Skåne University Hospital or Sahlgrenska University Hospital, with post-transplant follow-up conducted at the outpatient transplant clinics at the participating centers.\n\nEligible participants are adults (≥18 years) who undergo orthotopic HTx. Exclusion criteria include pregnancy, multi-organ transplantation, or a history of other solid organ or hematopoietic stem cell transplantation.\n\nPeripheral blood samples are collected according to standardized operating procedures and transported at ambient temperature to the immunology laboratory for processing. A subset of samples is immediately cryopreserved upon collection. Clinical and demographic data are extracted from the electronic medical record (EMR) using standardized data collection forms. The main outcome is the correlation between analyzed dd-cfDNA fraction levels and biopsy-proven rejection, defined by International Society of Heart and Lung Transplantation (ISHLT)'s histopathological criteria. The longitudinal changes in dd-cfDNA fraction and DSA will be analyzed as well as the association between DSA and dd-cfDNA fraction.",[54,23],"Heart Transplantation",[56],"heart transplantation rejection surveillence","2026-04-12",{"date":59,"type":32},"2026-04-15",{"date":61,"type":32},"2025-02-01",{"date":63,"type":19},"2036-12-31",{"name":65,"class":39},"Karolinska Institutet",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100495559","mobile-video-directly-observed-therapy-dot-for-immunosuppression-medication-adherence-in-adolescent-heart-transplant-recipients-100495559","NCT05732779","Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients","Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients: Enhancing Technological Innovation and Strengthening the Role of Small Businesses in Meeting Needs of Adolescent Organ Transplant","Inclusion Criteria:\n\n* Eligible participants are 10-21 years of age\n* Have received a heart transplant and are followed participating pediatric heart transplant centers\n* English-speaking or Spanish-speaking\n* Own a smart-phone or have access to the mobile app through other devices\n* Are willing to receive information through it\n* Have a MLVI score of greater than 2.0 over the last year\n\nExclusion Criteria:\n\n• Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent","10 Years","21 Years",{"count":77,"type":19},100,"INTERVENTIONAL",[80],"NA","We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.",[23,83,84,85,86,87,88],"Immune Suppression","Pediatric Heart Transplant","Medication Nonadherence","Health Behavior","Remote Monitoring","Patient Engagement","2026-02-24",{"date":91,"type":32},"2026-02-27",{"date":93,"type":32},"2024-10-01",{"date":95,"type":19},"2027-05-01",{"name":97,"class":39},"University of Florida",4,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100566506","imr-heart-trasplant-study-100566506","NCT06656065","IMR-Heart Trasplant Study","Index Microvascular Resistance (IMR) in Heart Transplant Patients","Inclusion Criteria:\n\n* Heart transplant patients \\>18 years.\n* Patients who have received and signed informed consent.\n\nExclusion Criteria:\n\n* Patients with hemodynamic instability after HT, including cardiogenic shock or severe coagulopathy.\n* Patients with acute cellular rejection before intracoronary physiological assessment.\n* Patients with bronchial asthma or bronchopathy with a positive bronchodilation test, which contraindicates the use of adenosine.\n* Patients with epicardial coronary lesions with a resting physiological index ≤0.89 or ≤0.80 at hyperemia.\n* Patients unlikely to cooperate or with inability or unwillingness to give informed consent.",{"count":77,"type":19},"Acute allograft rejection (AAR) is an important cause of morbi-mortality in heart transplant (HT) patients, particularly during the first year. Endomyocardial biopsy (EMB) is the \"gold standard\" to guide post- heart transplantation treatment. However, it is associated with complications that can be potentially serious. The index of microvascular resistance (IMR) is a specific physiological parameter used to assess microvascular function. Invasive coronary assessment has been shown to be both feasible and safe. Detection of coronary microvascular dysfunction (MCD) by IMR may help to identify high risk HT patients. In fact, an increased IMR measured early after HT has been associated with AAR, higher all-cause mortality and adverse cardiac events. A high IMR value early after HT may identify patients at higher risk who require increased surveillance or adjustments in immunosuppressive therapy. Conversely, a low IMR value may support reducing the number of EMBs. Our aim is to evaluate IMR in heart transplant patients within the first year. Changes in management after knowing IMR values and prognostic implications of IMR in a long term follow up will also be assessed.",[23,109],"Microvascular Resistance",[111,112,113,114],"Heart Trasplant","Acute cellular rejection","IMR","Endomyocardial biopsy","2025-11-18",{"date":117,"type":32},"2025-11-21",{"date":119,"type":32},"2023-05-23",{"date":121,"type":19},"2028-10-14",{"name":123,"class":39},"Hospital Miguel Servet",2,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":140,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":4},"100498606","cardiac-transplant-metabolomics-with-and-without-rejection-100498606","NCT05772442","Cardiac Transplant Metabolomics With and Without Rejection","Investigating the Metabolomic Profile of Transplanted Heart With and Without Pathological Signs of Rejection","ANTIPARTICLE","Inclusion Criteria:\n\n* All patients with heart transplant undergoing routine endomyocardial biopsy and blood work for transplant rejection screening and workup.\n* Patients or substitute decision makers are able to provide informed consent to agree to participate in this study.\n\nExclusion Criteria:\n\n* Patients or substitute decision makers declined to participate in this study.",{"count":77,"type":19},"Patient who received a heart transplant may develop organ rejection. Currently, an invasive biopsy of the heart needs to be performed to diagnose rejection. The purpose of this research study is to identify novel metabolic biomarkers that can be developed into a blood test that can identify signs of rejection without doing a heart biopsy.",[23],[137,138,139],"Transplant","Metabolomics","Rejection","NOT_YET_RECRUITING","2024-07-22",{"date":143,"type":32},"2024-07-23",{"date":145,"type":19},"2024-07",{"date":147,"type":19},"2026-04",{"name":149,"class":39},"Western University, Canada"]