[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heart-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heart-transplantation":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,40,67,91,112,140,166,191,217,245,273,314,338,368,393,416,459,489,506,527,543,570,604,626,645],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100575598","cardiac-imaging-and-biomarkers-in-the-diagnosis-of-antibody-mediated-rejection-in-heart-transplantation-100575598",false,"NCT06774365","CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation","CARIBIAM","Inclusion Criteria:\n\n* Age \\> 18 years\n\n  * Post heart transplantation follow-up between 1 and 15 y\n  * Ambulatory clinical stable\n  * Left ventricular ejection fraction (LVEF) \\> 40% (as assessed by complete cardiac ultrasound within 3 months before the enrolment)\n\nExclusion Criteria:\n\n* Unplanned hospitalization for cardiovascular causes in the previous three months\n\n  * Biopsy-proven cellular (2R or greater) or AMR (pAMR\\> 1 ) in the previous 3 months\n  * Any contraindication to CMR\n  * Known pregnancy","ALL","18 Years",{"count":19,"type":20},683,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to systematically assess the presence and distribution of CMR-defined inflammation and fibrosis in clinically stable HT recipients with DSA detected during active screening for AMR surveillance. The main outcome is to study the prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA and the prevalence of patients with DSA among all the enrolled patients",[24,25,26],"Heart Transplantation","Rejection Heart Transplant","HLA Antigens","RECRUITING","2026-05-20",{"date":30,"type":31},"2026-05-22","ACTUAL",{"date":33,"type":31},"2024-11-07",{"date":35,"type":20},"2029-12",{"name":37,"class":38},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",4,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100509109","phase-2-hypertonic-saline-solution-to-prevent-acute-kidney-injury-after-heart-transplantation-100509109","NCT05909150","Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation","Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation","HSS-HTx","Inclusion Criteria:\n\n* Hospitalized patients submitted to orthotopic heart transplantation (HT)\n\nExclusion Criteria:\n\n* Requirement of renal replacement therapy at the time of HT\n* Requirement of extracorporeal membrane oxygenation (ECMO) before or immediately after HT\n* Severe peri-operative mechanical complications\n* Double transplant (e.g. heart-kidney or heart-lung)\n* Hypernatremia (Na ≥ 145)\n* Severe hyponatremia (Na ≤ 120)",true,{"count":50,"type":20},74,"INTERVENTIONAL",[53],"PHASE2","The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.",[24,56],"Acute Kidney Injury","2026-04-29",{"date":59,"type":31},"2026-05-06",{"date":61,"type":31},"2023-11-08",{"date":63,"type":20},"2027-03",{"name":65,"class":38},"Fernando Bacal",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"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.",{"count":76,"type":20},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.",[24,79],"Heart Transplant Rejection",[81],"heart transplantation rejection surveillence","2026-04-12",{"date":84,"type":31},"2026-04-15",{"date":86,"type":31},"2025-02-01",{"date":88,"type":20},"2036-12-31",{"name":90,"class":38},"Karolinska Institutet",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":66},"100495271","the-evolution-of-systemic-microvascular-reactivity-in-heart-transplant-patients-100495271","NCT05729009","The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients","Inclusion Criteria:\n\n* capability to understand the objectives of the research and to fulfill the Term of Consent\n\nExclusion Criteria:\n\n* Pregnancy, acute infection diagnosis, use of circulatory assistance devices","75 Years",{"count":99,"type":20},31,"The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.",[24],"2026-04-07",{"date":104,"type":31},"2026-04-13",{"date":106,"type":31},"2022-10-01",{"date":108,"type":20},"2026-12",{"name":110,"class":111},"National Institute of Cardiology, Laranjeiras, Brazil","OTHER_GOV",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":51,"phases":121,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":66},"100620218","precise-cooler-for-donor-heart-transport-100620218","NCT07354763","Precise Cooler for Donor Heart Transport","Adjustable Temperature Cooler for Cold Static Storage of Donor Hearts for Transplantation","Inclusion Criteria:\n\n* Individuals 18 years old or older are included.\n* Individuals undergoing isolated heart transplantation are included.\n\nExclusion Criteria:\n\n* Any records flagged \"break the glass\" or \"research opt out.\"\n* Any patients undergoing multi-organ transplantation.",{"count":120,"type":20},80,[122],"NA","The investigators are doing this study to compare approaches to cold storage of donor hearts during transportation. The adjustable temperature RYOBI cooler should allow precise temperature control while reducing environmental waste and providing a cost savings benefit when compared to the commercially available, FDA-approved Paragonix SherpaPak device.",[24],[126,127,128,129],"Donor heart","Heart transplantation","organ procurement","heart failure","NOT_YET_RECRUITING","2026-03-17",{"date":133,"type":31},"2026-03-18",{"date":135,"type":20},"2026-04-01",{"date":137,"type":20},"2027-12-01",{"name":139,"class":38},"Cedars-Sinai Medical Center",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":17,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":66},"100541086","exercise-mri-to-evaluate-cardiorespiratory-fitness-in-children-with-heart-disease-100541086","NCT06325280","Exercise MRI to Evaluate Cardiorespiratory Fitness in Children With Heart Disease","Utilizing Exercise Cardiovascular and Skeletal Magnetic Resonance Imaging to Evaluate Factors Associated With Cardiorespiratory Fitness in Children With Acquired and Congenital Heart Disease","Inclusion Criteria:\n\n* 10 - 18 year olds followed at the Stollery Children's Hospital\n* Heart transplant recipients ≥6 months post-transplant\n* Have a moderate-complex congenital heart disease diagnosis\n\nExclusion Criteria:\n\n* Non-English speaking\n* Exercise restricted by the patient's clinical cardiologist\n* Clinical antibody- or cellular-mediated rejection within 3-months of the assessment or during the study period (for HTRs)\n* Previous involvement in a CR or exercise intervention program\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; unrepaired\u002Funpalliated CHD\n* Arrhythmias in the last year (including supraventricular tachycardia, ventricular tachycardia, atrioventricular block or history of (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 exercise MRI\n* Research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing\n* Extracardiac or congenital abnormality limiting the participant's functional ability to exercise\n* Pregnant","10 Years",{"count":149,"type":20},20,"There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.",[152,153,24],"Pediatric ALL","Congenital Heart Disease",[155,156],"Pediatric cardiology","Exercise cardiac MRI","2026-03-12",{"date":159,"type":31},"2026-03-16",{"date":161,"type":31},"2025-01-20",{"date":163,"type":20},"2027-12-31",{"name":165,"class":38},"University of Alberta",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":51,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":190},"100518565","phase-2-study-of-organ-perfusion-in-heart-transplantation-in-children-100518565","NCT06032195","Study of Organ Perfusion in Heart Transplantation in Children","A Prospective Randomized Single Blind Multicenter Phase II Study of Organ Perfusion With Custodiol-N Compared With Custodiol in Heart Transplantation in Children","Inclusion Criteria:\n\n* Age from birth to less than18 years\n* Recipients awaiting their first transplant\n* Ability of the patients and\u002F or their legal guardians to understand character and individual consequences of the clinical trial\n* written informed consent of the patients and\u002F or their legal guardians (must be available before enrolment in the study)\n* Patient listed on the waiting list for heart transplantation\n\nExclusion Criteria:\n\n* Patients who have participated within 30 days or are still participating in any other interventional studies\n* history of severe organic disease other than concerning the heart\n* history\u002Fdemonstration of HIV antibodies or AIDS\n* multiorgan transplantation\n* machine-perfused organ\n* the explantation team is affiliated to another clinic than transplantation team\n* Failing Fontan patients\n* Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities\n* Pregnancy and lactation","24 Hours","17 Years",{"count":176,"type":20},15,[53],"The goal of this prospective randomized single blind multicenter phase II study is to compare organ perfusion with Custodiol-N and Custodiol in heart transplantation in children of all ages (birth to \\\u003C18 years) being listed on the waiting list for heart transplantation. The main question it aims to answer is:\n\nto compare the safety of Custodiol-N in heart transplantation in children in comparison to its precursor product Custodiol.\n\nParticipants will receive either a heart to be transplanted, either perfused with Custodiol-N or Custodiol to Researchers will compare the two solutions to see if the new solution Custodiol-N is safe in heart transplantation in children.",[24],"2026-01-28",{"date":182,"type":31},"2026-01-30",{"date":184,"type":31},"2023-08-15",{"date":186,"type":20},"2027-09",{"name":188,"class":189},"Dr. F. Köhler Chemie GmbH","INDUSTRY",3,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":66},"100621607","metabolic-deterioration-in-htx-determines-outcomes-100621607","NCT07372820","METABolic Deterioration in HTX Determines Outcomes","METAB-HTX: Prospective, Longitudinal Cohort Study Evaluationg Cardiac and Systemic Metabolism After Heart Transplantation","METAB-HTX","Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Planned or already conducted heart transplantation\n* Informed consent\n\nExclusion Criteria:\n\n* Absence of informed consent",{"count":200,"type":20},270,"METAB-HTX is a prospective, longitudinal cohort study evaluating cardiac and systemic metabolism in heart transplant recipients.",[24],[204,205,206,207,129,208],"cardiac metabolism","Systemic Metabolism","cardiac function","heart transplant","Type 2 diabetes","2026-01-20",{"date":180,"type":31},{"date":212,"type":31},"2025-07-24",{"date":214,"type":20},"2032-02-01",{"name":216,"class":38},"Heinrich-Heine University, Duesseldorf",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":225,"conditions":226,"keywords":233,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":66},"100620597","multimodal-analysis-of-endomyocardial-biopsies-100620597","NCT07359690","Multimodal Analysis of Endomyocardial Biopsies","Inclusion Criteria:\n\n* Patients aged \\>18 years with a clinical indication for endomyocardial biopsy.\n* Patients capable of providing informed consent who have signed the consent form for participation in the study.\n\nExclusion Criteria:\n\n* Patients without a clinical indication for endomyocardial biopsy (EMB).\n* Pregnant individuals.\n* Patients incapable of providing informed consent.\n* Women of childbearing potential who are not using adequate contraception.",{"count":224,"type":20},216,"The goal of this observational study is to pursue a multimodal approach to identify the molecular signatures and immune signalling molecules of various myocardial diseases and thereby contribute to improving diagnosis and therapy.\n\nThe main aim is:\n\n-Identification of molecular profiles (e.g., proteome, lipidome, metabolome) and immune signalling profiles that are specifically associated with different myocardial diseases and the post-heart transplantation course.\n\nParticipants already receiving an endomyocardial biopsy as part of their regular medical care will be enrolled. An additional biopsy sample will be taken for the above mentioned research.",[24,227,228,229,230,231,232],"Dilated Cardiomyopathy (DCM)","Hypertrophic Cardiomyopathy (HCM)","Myocarditis, Pericarditis","Amyloidosis Cardiac","Cardiomyopathies","Sarcoidosis of the Heart",[234,235],"Endomyocardial biopsy","Multimodal analysis","2026-01-15",{"date":238,"type":31},"2026-01-22",{"date":240,"type":31},"2025-10-27",{"date":242,"type":20},"2028-09-30",{"name":244,"class":38},"University Hospital, Essen",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":66},"100620692","pericoronary-adipocyte-size-gradient-100620692","NCT07360925","Pericoronary Adipocyte Size Gradient","Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue","AdipoCor","Inclusion Criteria:\n\n* Age 30-90 years\n* Diagnosis of dilatational or ischemic cardiomyopathy\n* Patients undergoing heart transplantation in IKEM\n\nExclusion Criteria:\n\n* Known combined diagnosis of dilatational and ischemic cardiomyopathy\n* Arrhythmogenic cardiomyopathy\n* Congenital heart defects\n* Non-eligibility due to the absence of informed consent","30 Years","90 Years",{"count":256,"type":20},60,"Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.",[259,24],"Heart Failure",[261,262,263,264],"Pericoronary adipose tissue","adipocyte size","inflammatory changes","macrophages","2026-01-14",{"date":238,"type":31},{"date":268,"type":31},"2023-06-01",{"date":270,"type":20},"2029-07-01",{"name":272,"class":111},"Institute for Clinical and Experimental Medicine",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":48,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":282,"conditions":283,"keywords":296,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":66},"100615334","long-term-follow-up-of-the-offspring-born-to-mothers-with-a-solid-organ-transplant-transplantlines-next-generation-100615334","NCT07291258","Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation","Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant","Inclusion Criteria:\n\n* Mother with a KTx, LiTx, PTx (including pancreas islet transplantation), HTx or LuTx before pregnancy (including mothers with multiple transplantation types)\n* Age ≥16 years for offspring born to mother with a KTx or LiTx\n\nExclusion Criteria:\n\n* No informed consent\n* Non Dutch or English speaking",{"count":281,"type":20},200,"Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Thus, the development of the unborn child seems to be affected by the transplant and its consequences such as the immunosuppressive medication use. Worldwide data regarding follow-up after birth is scarce. The very limited existing data existing only in young children are reassuring. However, the investigators hypothesize that there are health risks for the children. Given the side effects of the immunosuppressive medication on patients and limited knowledge from animal studies, the investigators particularly expect cardiovascular effects such as hypertension and kidney damage. These develop over a long time-period and lead late to symptoms.\n\nAims Aim of this study is to gain more insight into the overall health of offspring born after SOT. Primary aim is to assess the cardiovascular health and the presence of kidney disease, and compare these with reference values from the general population or birth cohorts. Secondary aims are the immunological status including the microbiome of the child given the maternal immunosuppressive medication use, and the overall development of the offspring, including qualitative research regarding the quality of life. Third aim is to assess if there are differences in health between offspring born to mothers with a kidney, liver, pancreas (including pancreas islet), heart and lung transplantation (KTx, LiTx, PTx, HTx, LuTx resp.). The investigators also want to establish a biobank for later follow-up research.\n\nStudy design This will be a cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. The investigators estimate that there will be about 150(-220) participants. Before the study visit, participants will be asked to complete a questionnaire. Participants will be invited for a one-time study visit consisting of physical tests (including ultrasound of the kidneys and a 24-hour ambulatory blood pressure measurement) and biological sample (urine, blood and feces) collection, including sample collection for biobanking. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. As a control group pseudoanonymized data from the Lifelines cohort will be used.\n\nDeliverables To the best of our knowledge, this will be the first study worldwide that will gather and analyze detailed information about the cardiovascular, kidney and immunological health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, PTx, HTx and LuTx. This information will be important for the preconceptional counseling of families with a pregnancy wish after transplantation and thereby contribute to the health of women with a SOT. Next to that, find adverse effects of the pregnancy after transplantation on the offspring are found, the investigators expect there will be modifiable factors and\u002For early screening\u002Finterventions that can reduce these risks and thereby contribute to the health of the offspring.",[284,285,286,287,288,289,24,290,291,292,293,294,295],"Solid Organ Transplantation","Pregnancy","Long-term Follow-up","Kidney Transplant","Liver Transplant","Pancreas Transplant","Lung Transplantation","Offspring, Adult","Children","Cardiovascular Abnormalities","Kidney Disease","Quality of Life",[297,285,298,299,300,301,302,303,127,304],"Solid organ transplantation","Offspring","Long-term follow-up","kidney transplantation","liver transplantation","pancreas transplantation","pancreas islet transplantation","lung transplantation","2025-12-04",{"date":307,"type":31},"2025-12-18",{"date":309,"type":31},"2025-10-15",{"date":311,"type":20},"2028-06",{"name":313,"class":38},"University Medical Center Groningen",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":321,"targetDuration":4,"studyType":51,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100399165","phase-2-belatacept-in-de-novo-heart-transplantation-100399165","NCT04477629","Belatacept in De Novo Heart Transplantation","Belatacept in De Novo Heart Transplantation - Pilot Study","Inclusion Criteria:\n\n1. Male or non-pregnant female, age ≥18 to ≤75 years\n2. Awaiting a primary heart transplant (listed for heart transplant only)\n3. Epstein-Barr virus (EBV) IgG seropositive\n4. Able to take oral medication and willing to adhere to the belatacept infusion regimen\n5. No desensitization therapy prior to transplant\n6. Vaccinations should be up to date for hepatitis B, influenza pneumococcal, haemophilus, varicella zoster virus (VZV), measles, mumps and rubella (MMR), and Human Papilloma Virus (HPV) (for participants \\\u003C 45 years of age) when available\n7. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization\n8. Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted\n9. Negative virtual crossmatch\n\nExclusion Criteria:\n\n1. Candidates awaiting multiorgan transplant\n2. Estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002Fm2\n3. Candidates with prior organ transplant\n4. Candidates actively being treated with immunosuppressive therapies\n5. Candidates who have a history of treatment with cytolytic therapy (e.g. anti-thymocyte globulin)\n6. Candidates who are intended to be treated with cytolytic therapy in the post-transplant period as induction therapy\n7. EBV (IgG) seronegative\n8. Active or prior infection with human immunodeficiency virus (HIV), Hepatitis C (HCV), Hepatitis B (HBV)\n9. Untreated latent tuberculosis (TB)\n10. All potential candidates will be screened prior to enrolment for a history of tuberculosis (chest radiograph and tuberculosis-Interferon Gamma Release Assay (TB-IGRA) or tuberculin skin tests (TST)). Potential candidates with latent TB must be treated prior to study enrolment\n11. Prior history of active tuberculosis\n12. Prior history of central nervous system infection\n13. Known active current viral, fungal, mycobacterial, or other infections excluding driveline infections - potential participants from endemic areas will additionally be screened for histoplasmosis, blastomycosis, coccidioidomycosis, and strongyloidiasis\n14. Vaccination with a live vaccine within the past 30 days\n15. Malignancy within the last 5 years\n16. Any previous treatment with alkylating agents or total lymphoid irradiation\n17. Sensitized heart transplant candidates with panel-reactive antibodies (PRA) \\>50% or those receiving desensitization treatment\n18. Prior treatment with belatacept or abatacept\n19. History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies\n20. Treatment with a disease modifying anti-rheumatic drug (DMARD) or other biologic agent (monoclonal antibody) within the past year\n21. Treatment with another investigational drug or other intervention at the time of transplant (excluding device or intervention mechanical support or investigational drug trials where the intervention ends at the time of transplant)\n22. Potential candidates for whom a calcineurin inhibitor other than tacrolimus (Prograf®) is anticipated after transplant. If during the course of the study, a participant is transitioned to another calcineurin inhibitor due to side effects or inability to achieve stable therapeutic trough levels, they may continue in the study at the discretion of the investigator\n23. Any potential participant who remains on mechanical circulatory support for \\> 72 hours post-transplant will be excluded from the study\n24. The need for ongoing high dose vasopressor support \\> 72 hours post-transplant\n25. The need or anticipated need for post-transplant dialysis\n26. Platelet count \\\u003C75,000\u002Fmm (within 24 hours prior to transplant)\n27. Absolute neutrophil count (ANC) of less than 2000\u002Fmm3 within 24 hours prior to transplant\n28. Any past or current medical problems or findings on history, physical examination, or laboratory testing, not listed above, that in the opinion of the investigator, may pose additional risk to participation, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of study results",{"count":322,"type":20},12,[53],"The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).",[24],[327,328],"Heart Transplant","Nulojix","2025-12-02",{"date":305,"type":31},{"date":332,"type":31},"2020-08-06",{"date":334,"type":20},"2026-09",{"name":336,"class":38},"NYU Langone Health",2,{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":345,"targetDuration":147,"studyType":21,"phases":4,"briefSummary":347,"conditions":348,"keywords":356,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":66},"100600398","cardiac-rehabilitation-cohort-at-the-medicine-campus-davos-to-investigate-recovery-100600398","NCT07096973","Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery","RECOVER","Inclusion Criteria:\n\n* Patients undergoing CR at the HGK\n* Written informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language to understand study documents, the interview, or questionnaires interview without translation\n* Physical or psychological incapability to participate in the study",{"count":346,"type":20},10000,"The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos. The study is sponsored by Medicine Campus Davos AG and the Kühne Foundation, with an estimated start date in July 2025 and planned completion by December 2034, with the possibility of extension.\n\nThe principal investigator of the study is PD Dr. David Niederseer from Hochgebirgsklinik Davos, who also represents the study. The research team includes co-investigators such as Prof. Dr. Stefan Blankenberg and Prof. Dr. Andreas Ziegler from Cardio-CARE, Medicine Campus Davos, as well as Dr. Jan Vontobel from Hochgebirgsklinik Davos.\n\nThe study will enroll patients referred to Hochgebirgsklinik Davos for cardiac rehabilitation who provide informed consent. Cardiac rehabilitation is an evidence-based therapy for patients with heart disease, including those who have undergone cardiac procedures or surgeries.\n\nThe primary objectives are to evaluate baseline patient characteristics, rehabilitation strategies, predictors of recovery, and clinical outcomes during and after rehabilitation. To support this, a detailed database and biobank will be established to allow for comprehensive phenotyping, extensive clinical assessments, and long-term follow-up.\n\nRECOVER seeks to gain translational insights into how patient-specific factors - such as genetics, plasma, digital and clinical biomarkers, and comorbidities - influence long-term clinical outcomes. The goal is to identify modifiable risk factors to optimize individualized therapeutic approaches in cardiac rehabilitation.",[349,259,350,351,352,353,354,24,355],"Cardiac Rehabilitation","Cardiac Arrest (CA)","ACS (Acute Coronary Syndrome)","CABG","Valve Anomalies","LVAD (Left Ventricular Assist Device)","Arrhythmia",[357,358],"cardiovascular diseases","cardiac rehabilitation","2025-09-11",{"date":361,"type":31},"2025-09-17",{"date":363,"type":31},"2025-08-05",{"date":365,"type":20},"2040-08-05",{"name":367,"class":38},"Hochgebirgsklinik Davos",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":66},"100591590","zeroheart-biopsy---prediction-of-deceased-donor-heart-transplant-performance-from-organ-donors-using-pre-transplant-biopsies---a-pilot-study-100591590","NCT06982404","ZeroHeart Biopsy - Prediction of Deceased Donor Heart Transplant Performance From Organ Donors Using Pre-Transplant Biopsies - A Pilot Study","ZeroHeart","Inclusion Criteria:\n\nAll hearts from standard and expanded criteria donors as well as donor hearts from Donation after circulatory death (DCD) undergoing a heart biopsy at pre-implantation (at procurement) will be included. Consent will be obtained from the recipient at the time of transplant listing.\n\nExclusion Criteria:\n\nHearts will be excluded from the study if the participating clinician decides to discard the organ before transplantation or the recipient declines that the biopsy will be performed at the organ procurement.",{"count":376,"type":20},50,"The goal of this observational study is to evaluate whether molecular analysis of donor heart biopsies taken at the time of organ removal (\"Time Zero\") can help predict the future function and rejection risk of the transplanted heart in adult transplant recipients.\n\nThe main questions it aims to answer are:\n\n* Can early molecular injury in the donor heart, caused by brain death or circulatory death, be detected at the time of organ removal?\n* Can these early molecular findings predict short-, mid-, and long-term transplant outcomes, such as graft function or rejection?\n\nParticipants will:\n\n* Include heart donors whose hearts are being transplanted (both standard and marginal donors, including DBD and DCD cases)\n* Provide two small biopsies from the donor heart at the time of organ removal: one for routine pathology, one for microarray-based molecular analysis\n* Have routine follow-up biopsies after transplantation as part of standard care (no additional procedures required beyond medical standard)\n\nResearchers will compare biopsy results from different donor types (standard vs. marginal, DBD vs. DCD) to see if early molecular signals are linked to later heart transplant outcomes.",[24,379,380,381,382,383],"Graft Rejection","Myocardial Injury","Organ Preservation","Biopsy","Gene Expression Profiling","2025-05-13",{"date":386,"type":31},"2025-05-21",{"date":388,"type":31},"2025-05-12",{"date":390,"type":20},"2028-05-31",{"name":392,"class":38},"Medical University of Vienna",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":51,"phases":403,"briefSummary":404,"conditions":405,"keywords":406,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":66},"100460075","haemoadsorption-during-heart-transplantation-100460075","NCT05270902","Haemoadsorption During Heart Transplantation","Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation","CytoSorbHTX","Inclusion Criteria:\n\n* Adult patients undergoing heart transplantation\n\nExclusion Criteria:\n\n* Declined informed consent\n* Age \\\u003C 18 years#\n* Receiving antileukocyte drugs\n* Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)\n* DCD\n* Ex-vivo perfusion",{"count":402,"type":20},40,[122],"To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated",[24],[24,407],"Cytosorb","2025-05-06",{"date":410,"type":31},"2025-05-09",{"date":412,"type":31},"2022-09-01",{"date":414,"type":20},"2026-06-30",{"name":392,"class":38},{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":424,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":427,"conditions":428,"keywords":442,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":190},"100578603","characterization-of-patients-with-cardiomyopathy-to-identify-critical-patients-candidates-for-cardiac-transplantation-100578603","NCT06813443","Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation","Clinical, Instrumental, and Molecular (Circulating and Tissue microRNAs) Characterization of Patients With Cardiomyopathy to Identify Critical Patients With Severe Organ Failure to be Candidates for Cardiac Transplantation","CMPMIRNA","Inclusion Criteria:\n\n* Patients diagnosed with CMP according to current international guidelines\n* Age ≥ 12 years at the time of diagnosis\n* Obtaining informed consent from the patient and the parent or legal guardian (in the case of patients aged \\\u003C 18 years)\n\nExclusion Criteria:\n\n* none","12 Years",{"count":426,"type":20},700,"The study aims to identify new diagnostic and prognostic markers for CMP that can help predict disease progression. In particular, the study will focus on microRNAs (miRNAs) and spatial transcriptomics, which are emerging techniques that may provide insights into the underlying disease mechanisms. By understanding these markers, the investigators hope to improve the way the investigators diagnose and manage CMP, particularly in terms of predicting progression to heart failure or heart transplantation.\n\nThe study will evaluate patients with hypertrophic cardiomyopathy (e.g., sarcomeric forms, Anderson-Fabry disease, AL, and TTR cardiac amyloidosis), dilated cardiomyopathy and arrhythmogenic cardiomyopathy. These patients will undergo clinical evaluations, including ECG, echocardiograms, CMR, biopsy analysis, and genetic testing, as well as molecular studies such as transcriptomics and miRNA analysis. This comprehensive approach aims to identify potential new biomarkers for diagnosing and predicting the disease course.",[231,230,429,430,228,431,432,433,434,435,24,436,437,438,439,440,441],"Fabry Disease","Arrhythmogenic Cardiomyopathy","Laminopathies","Dystrophia Myotonica","Mitochondrial Cardiomyopathy","Dilated Cardiomyopathy","Sudden Cardiac Death","Glycogen Storage Disease","Infiltrative Cardiomyopathy","Cardiac Magnetic Resonance Imaging","Electrocardiogram","Micro RNA","Echocardiogram",[443,444,445,446,447,448,449,129,450],"cardiomyopathy","cardiac amyloidosis","Fabry disease","hypertrophic cardiomyopathy","dilated cardiomyopathy","sudden cardiac death","arrhythmogenic cardiomyopathy","heart transplantation","2025-02-03",{"date":453,"type":31},"2025-02-07",{"date":455,"type":31},"2023-02-13",{"date":457,"type":20},"2027-12-14",{"name":37,"class":38},{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":51,"phases":470,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":66},"100433466","phase-1-cell-therapy-with-treg-cells-obtained-from-thymic-tissue-thytreg-to-prevent-rejection-in-heart-transplant-children-100433466","NCT04924491","Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children","Randomized, Exploratory and Prospective Phase I\u002FII Clinical Trial to Evaluate the Safety and Efficacy of the Transfusion of Autologous Treg Cells Obtained From Thymic Tissue in the Prevention of Rejection in Heart Transplant Children","THYTECH","Inclusion Criteria:\n\n1. Patient under two years of age, who meets all the necessary requirements to undergo a heart transplant.\n2. Patients without contraindication to immunosuppressive drugs.\n3. Parents and\u002For guardians must be willing and able to understand the purpose and risks of the study and must sign the informed consent document\n\nExclusion Criteria:\n\n1. Patients with DiGeorge Syndrome, since their thymic function is affected.\n2. Human immunodeficiency virus positive serology\n3. Epstein-Barr virus active infection\n4. Patients hyperimmunized with cytotoxic anti-human leukocyte antigen antibodies\n5. Patients with a history of previous malignancy\n6. Patients who have participated in other intervention studies in the last month.\n7. Patients who have received induction therapy with Basiliximab or Thymoglobulin.\n8. Patients who have previously been thymectomized or transplanted.\n9. Patients who have been diagnosed with severe autoimmune disease (celiac disease, autoimmune hypothyroidism, autoimmune diabetes)\n10. Patients who will receive an asystole heart","2 Years",{"count":469,"type":20},11,[471,53],"PHASE1","The investigators developed a protocol to isolate Treg cells from thymic tissue (thyTreg) discarded in pediatric cardiac surgeries. After completing the pre-clinical studies, the investigators have initiated a phase I\u002FII clinical trial to test the safety and efficacy of the adoptive transfer of autologous thyTreg to prevent rejection in heart transplant children.\n\nCondition or disease: Heart Transplantation Intervention\u002Ftreatment: Regulatory T Cell (Treg) Infusion",[24],[475,476,477,478,479,480],"Cardiac Disease","Regulatory T cell","Immunomodulation","Tolerogenic protocol","Immunosuppressive Agents","Immunologic Factors","2025-01-30",{"date":451,"type":31},{"date":484,"type":31},"2020-09-10",{"date":486,"type":20},"2026-12-31",{"name":488,"class":38},"Rafael Correa-Rocha",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":505,"locationsCount":66},"100575631","precision-medicine-in-the-management-of-heart-transplant-recipients-100575631","NCT06774794","Precision Medicine in the Management of Heart Transplant Recipients","Precision Medicine in the Management of the Heart Transplant Patient: Advanced Molecular and Imaging Approaches","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have received an orthotopic heart transplant\n* Clinical indication for performing a myocardial biopsy (either as part of standard monitoring or for suspected rejection)\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* Severe complications in the post-operative phase that may limit the patient's short-term survival.",{"count":281,"type":20},"The goal of this clinical trial is to demonstrate that a multiparametric approach, based on the integration of biomolecular, histological, imaging, and clinical information, along with the use of machine learning methods, can identify among heart transplant patients those at higher risk of rejection, infectious events, and chronic graft dysfunction.\n\nPatients have been and will be treated according to clinical practice, in accordance with the physician's judgment and the information provided in the Technical Data Sheet of each individual product used in concomitant therapies, if administered according to clinical practice. The diagnostic-therapeutic pathway of the patients will not be in any way influenced by the results of tissue tests performed for the purposes of the study",[24],"2025-01-09",{"date":501,"type":31},"2025-01-14",{"date":503,"type":31},"2023-09-04",{"date":163,"type":20},{"name":37,"class":38},{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":524,"leadSponsor":526,"locationsCount":337},"100575629","use-of-machine-learning-algorithms-biomarkers-and-measures-of-quality-of-life-to-personalize-medical-management-of-liver-and-heart-transplant-recipients-100575629","NCT06774768","Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients","DARE","Retrospective cohort Inclusion criteria Receiving a heart or liver transplantation at IRCCS AOUBO between January 2008 and December 2020.\n\nSurviving at least 6 months after surgery Receiving at least one outpatient clinical assessment, comprising clinical evaluation, standard laboratory tests, and graft ultrasound Older than 18 years old\n\nExclusion criteria Unavailability of medical records in the standard data repositories of IRCCS AOUBO\n\nProspective cohort\n\nInclusion criteria Older thant 18 years old Receiving a heart or liver transplantation at least 6 months before study entry and being in active follow up at IRCCS AOUBO Obtaining informed consent\n\nExclusion criteria None",{"count":514,"type":20},1000,"This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO).\n\nThis clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.",[517,518,24,519,520,521],"Artificial Intelligence (AI)","Hepatocellular Carcinoma (HCC)","Liver Transplantation","Machine Learning","Major Cardiovascular Event",{"date":501,"type":31},{"date":481,"type":20},{"date":525,"type":20},"2029-12-31",{"name":37,"class":38},{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":534,"targetDuration":535,"studyType":21,"phases":4,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":66},"100575540","electronic-register-on-advanced-heart-failure-and-transplantation-di-cuore-100575540","NCT06773611","Electronic Register on Advanced Heart Failure and Transplantation di Cuore","Electronic Register on Advanced Heart Failure and Transplantation","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Ability to provide informed consent\n* Diagnosis of Advanced Heart Failure or Heart Transplant\n\nExclusion Criteria:\n\n* none",{"count":346,"type":20},"5 Years","The goal of this observational study is to create an electronic registry of patients diagnosed with Advanced Heart Failure or Heart Transplant, starting from 01\u002F01\u002F1985 and to assess the incidence of Advanced Heart Failure and Heart Transplant, and characterize patients affected by the first or undergoing the second procedure, starting from 01\u002F01\u002F1985. The primary outcomes are:\n\n* Hospitalization for cardiovascular cause\n* Death",[259,24],{"date":501,"type":31},{"date":503,"type":31},{"date":541,"type":20},"2028-09",{"name":37,"class":38},{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":51,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":66},"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":553,"type":20},160,[122],"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.",[259,557,558,559,24,560],"Arrhythmia, Ventricular","Cardiomyopathy Ischemic","Catheter Ablation","Left Ventricular Assist Device","2024-12-01",{"date":563,"type":31},"2024-12-04",{"date":565,"type":31},"2024-09-13",{"date":567,"type":20},"2027-01-01",{"name":569,"class":38},"Heart and Diabetes Center North-Rhine Westfalia",{"id":571,"slug":572,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":51,"phases":580,"briefSummary":581,"conditions":582,"keywords":585,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":66},"100542336","quantiferon-cmv-to-identify-treatment-need-for-asymptomatic-cmv-infection-after-solid-organ-transplant-quantifot-100542336","NCT06341543","Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)","Use of QuantiFERON® CMV in the Therapeutic Decision in Asymptomatic CMV Infection in Solid Organ Transplant Recipients","QUANTIFOT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Solid organ transplant recipient (heart, kidney, liver and lung)\n* Detectable CMV viral load between 1,000 and 15,000 IU\u002FmL (including 2 borderline values):\n\n  * Asymptomatic (no fever or organ dysfunction) ;\n  * Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;\n  * Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.\n* Having signed an informed consent form.\n* Affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Presence of anti-Herpesviridae treatment when CMV replication is detected (\\[val\\]aciclovir, \\[val\\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).\n* Pregnant or breast-feeding women.\n* Persons under guardianship or trusteeship.\n* Subjects under administrative or judicial supervision.\n* Subject unable to be contacted in case of emergency.",{"count":579,"type":20},288,[122],"Context\n\nCytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.\n\nMost of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and\u002For disease, and who ill benefit the most from antiviral therapy.\n\nAs CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).\n\nAim of the study\n\nThe aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.\n\nMethods\n\nParticipation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU\u002FmL.\n\nThe QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).\n\n* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.\n* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.\n\nIn the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).\n\nThe participants will be sampled:\n\n* 5 to 12 days after QF-CMV sampling (V2) ;\n* 7 to 14 days days after V2 (V3 - between D12 and D26) ;\n* 7 to 14 days days after V3 (V4 - between D19 and D40) .\n\nEndpoints\n\nThe primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:\n\n* Blood CMV viral load \\>10,000 IU\u002FmL \\[4 log\\];\n* And\u002For increase in blood viral load ≥0.5 log IU\u002FmL with CV otherwise \\>5000 IU\u002FmL;\n* And\u002For the onset of CMV disease.\n\nThe secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).",[583,24,584,290,519],"Cytomegalovirus Infections","Kidney Transplantation",[586,587,588,589,590,591,592,593,594],"solid organ transplantation","cytomegalovirus","CMV","quantiferon","IGRA","interferon gamma release assay","antiviral","adverse effect","viremia","2024-09-27",{"date":597,"type":31},"2024-10-01",{"date":599,"type":31},"2024-09-24",{"date":601,"type":20},"2026-10",{"name":603,"class":38},"University Hospital, Grenoble",{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":66},"100517024","genomics-in-heart-transplants-100517024","NCT06012162","Genomics in Heart Transplants","Long-read Genome Sequencing and Risk Stratification of Myocardial Ischemia in Patients With Heart Transplantation","Inclusion Criteria:\n\n* Patients \\> 18 years old undergoing heart transplantation in our centre\n\nExclusion Criteria:\n\n* \\\u003C 18 years\n* incapable of giving consent",{"count":281,"type":20},"A cross-sectional analysis of 200 heart transplant recipients, combining in-depth phenotyping and risk factor assessment (cardiac MRI, coronary angiogram with OCT, cardiorespiratory exercise tests, exogenic factors like nutrition, smoking, lipid profile) with short-read whole-genome sequencing to elucidate the interplay of established PRS from the literature and exogenic risk factors with respect to HTx outcomes will be carried out.\n\nBesides that, a long-read whole-genome sequencing of 100 newly transplanted recipients and their corresponding donors and extend latest bioinformatics methods developed by the study to analyze long-read data will be performed. This will enable a comprehensive and integrated analysis of structural variants, polygenic risk, high-penetrance variant genotypes, immunogenetic (major and minor histocompatibility), and individual lifestyle risk factors in a unique donor-recipient cohort, elucidating the extent of within-cohort variability and cross-correlations between the considered potential risk factors and an exploratory analysis of the utility of genetic risk scores in light of the study results will be carried out.",[24],[450,615,616,617],"long-read genomics","risk stratification","myocardial ischemia","2023-08-21",{"date":620,"type":31},"2023-08-25",{"date":622,"type":20},"2024-01",{"date":624,"type":20},"2028-01",{"name":216,"class":38},{"id":627,"slug":628,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":632,"targetDuration":147,"studyType":21,"phases":4,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":66},"100392681","impact-of-donor-heart-function-on-recipient-outcomes---a-prospective-study-to-increase-the-utilization-of-donor-hearts-100392681","NCT04393181","IMPact of Donor Heart Function on Recipient Outcomes - a prospectiVE Study to Increase the Utilization of Donor HEARTs","Inclusion Criteria:\n\n* Patient who has been accepted for heart transplantation at the participating transplantation center\n\n  * The research subject has given written consent to participate in the study\n  * Aged 18 years or older\n\nExclusion Criteria:\n\n* • Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation\n\n  * Another study, where the patient is included, which is not considered compatible with the current study.",{"count":633,"type":20},500,"Severe heart failure is a diagnosis with a very poor prognosis. Heart transplantation is the best treatment for terminal heart failure but this type of treatment is limited by the number of available organs. About 20-25% of possible donor hearts are not considered for transplantation because they have some form of functional impairment. The functional impairment affecting organ donors is, however, usually reversible. A number of retrospective studies show that cardiac function recovers and recipients of hearts with dysfunction do not have worse outcomes compared to recipients of hearts with perfect cardiac function. However, there are no prospective studies on whether the functional impairment of the donor heart is of significance for the recipient. With a systematic and simple investigation of the heart, it should be possible to identify the hearts that are safe to transplant. This will thus increase the number of available donors.",[24],"2022-04-29",{"date":638,"type":31},"2022-05-02",{"date":640,"type":31},"2022-04-05",{"date":642,"type":20},"2027-04-01",{"name":644,"class":111},"Vastra Gotaland Region",{"id":646,"slug":647,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":97,"enrollmentInfo":653,"targetDuration":535,"studyType":21,"phases":4,"briefSummary":654,"conditions":655,"keywords":660,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":665,"lastUpdatePostDateStruct":666,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":66},"100445490","stress-echo-2030-the-novel-abcde-fglpr-protocol-to-define-the-future-of-imaging-100445490","NCT05081115","Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging","The International Stress Echo Study to to Define the Future of Imaging","SE2030","Inclusion Criteria:\n\nKnown or suspected coronary artery disease Hypertrofic cardiomiopathy Repaired Tetralogy of Fallot Primary valvular disease\n\nExclusion Criteria:\n\n\\-",{"count":346,"type":20},"With stress echo (SE) 2020 study, a new standard of practice in stress imaging was developed and disseminated: the ABCDE protocol for functional testing within and beyond CAD. ABCDE protocol was the fruit of SE 2020, and is the seed of SE 2030, which is articulated in 12 projects: 1-SE in coronary artery disease (SECAD); 2- SE in diastolic heart failure (SEDIA); 3-SE in hypertrophic cardiomyopathy (SEHCA); 4- SE post-chest radiotherapy and chemotherapy (SERA); 5- Artificial intelligence SE evaluation (AI-SEE); 6- Environmental stress echocardiography and air pollution (ESTER); 7- SE in repaired Tetralogy of Fallot (SETOF) ; 8- SE in post-COVID-19 (SECOV); 9: Recovery by stress echo of conventionally unfit donor good hearts (RESURGE); 10- SE for mitral ischemic regurgitation (SEMIR); 11- SE in valvular heart disease (SEVA); 12- SE for coronary vasospasm (SESPASM). The study aims to recruit in the next 5 years (2021-2025) ≥10 000 patients followed for ≥5 years (up to 2030) from ≥20 quality-controlled laboratories from ≥10 countries. In this COVID-19 era of sustainable health care delivery, SE2030 will provide the evidence to finally recommend SE as the optimal and versatile imaging modality for functional testing anywhere, any time and in any patient.",[656,259,657,153,658,659,24],"Coronary Artery Disease","Hypertrophic Cardiomyopathy","Valvular Heart Disease","Post-chest Radio\u002FChemiotherapy",[661,662,663,664],"effectiveness","registry","stress echo","sustainability","2021-10-18",{"date":667,"type":31},"2021-10-26",{"date":669,"type":31},"2021-04-01",{"date":671,"type":20},"2030-12-31",{"name":673,"class":38},"Fatebenefratelli Hospital"]