[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06939751":3,"trial-entities:NCT06939751":160,"trial-summary:NCT06939751":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":35,"sex":36,"minimum_age":37,"maximum_age":38,"healthy_volunteers":39,"eligibility_criteria":40,"std_ages":54,"locations":57,"central_contacts":145,"overall_officials":150,"references":151,"see_also_links":159},"NCT06939751","Northwestern-2024-372","OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels","RECRUITING","2032-01-01","2026-08","2026-08-11","2025-10-28","Northwestern University","OTHER",null,"This study aims to develop and refine a microRNA (miR) biomarker panel that can be used to phenotype net immune state after heart transplantation using circulating miRs (associated with drug doses and levels). These miRs will be used to characterize the overall immune state in adult heart transplant patients and predict patients that will go on to develop infection and rejection. MicroRNAs (miRs) are small, non-coding RNA molecules that regulate gene expression and serve as molecular biomarkers found in the circulation.","The study objectives will be accomplished in a prospective, multicenter observational, longitudinal cohort study that includes \\~250 Heart Transplant patients from the United States. Patients will be screened for eligibility and enrolled \\~1 month (± 2 weeks) after transplant. Study participation will last 36 months.\n\nAll patients will follow the center's standard of care surveillance schedule after transplant. Blood samples will be collected for miR evaluation at:\n\n1. specified time intervals after transplant and\n2. when a clinical event of interest occurs, including treated rejection, or infection.\n\nResearch samples will be collected and used to evaluate miR expression as well as other biomarkers related to heart transplantation and immunosuppression medications. Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)\u002Fdonor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB) echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing.\n\nThis work will form the basis for a non-invasive, genomic blood test that can be used to monitor patients after heart transplant to mitigate complications of over-immunosuppression, such as infection, without increasing the risks of under-immunosuppression, such as rejection.",[18,19],"Cardiac Failure","Graft Rejection",[],"OBSERVATIONAL",[],{"count":24,"type":25},250,"ESTIMATED",[],[28,32],{"measure":29,"description":30,"timeFrame":31},"Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Infection in Pediatric Heart Transplant Recipients","A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of infection in heart transplant recipients. Infections are defined as any bacterial, viral, fungal, or opportunistic infection leading to: 1) hospitalization, 2) prescription of antimicrobial therapy, or 3) reduction in immunosuppression","up to 3 years post - transplant",{"measure":33,"description":34,"timeFrame":31},"Time-to-Event Analysis of Circulating microRNAs (miRs) Predicting Rejection in Pediatric Heart Transplant Recipients","A time-to-event analysis will be performed to identify specific circulating microRNAs (miRs) that predict the risk of rejection in heart transplant recipients. Rejection is defined as treated rejection based on 1) endomyocardial biopsy (EMB) pathology, 2) unexplained graft dysfunction, or 3) molecular testing; leading to treatment with pulse dose steroids, monoclonal antibodies, plasmapheresis, and\u002For intravenous immunoglobulin (IVIg).\n\nEMB Pathology: Acute Cellular Rejection (ACR) Grade ≥ 2R and\u002For Antibody-mediated Rejection (AMR) Grade ≥ pAMR1, per International Society for Heart and Lung Transplantation (ISHLT) grading systems.\n\nGraft Dysfunction: Left Ventricular Ejection Fraction (LVEF) decline ≥ 10% from baseline and \\\u003C 50% absolute LVEF by echocardiography.\n\nMolecular Testing: Presence of 2 of the following 3 criteria-presence of HLA-DSA, elevated donor-derived cell-free DNA (dd-cfDNA), or gene expression results from blood or EMB testing.",[],"ALL","18 Years","99 Years",false,{"inclusion":41,"exclusion":46,"raw_text":53},[42,43,44,45],"Age ≥ 18 years at enrollment","Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks","Planned follow-up at the transplant center for a minimum of one-year.","Patient able and willing to comply with the study visit schedule, study procedures, and study requirements.",[47,48,49,50,51,52],"Recipient of a multi-organ transplant","History of prior solid organ transplant before the index heart transplant","Ongoing mechanical circulatory support or hemodynamic instability (e.g., inotrope or vasopressor therapy)","Ongoing need for renal replacement therapy and\u002For dialysis","Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression","Active rejection being treated with intravenous medications or plasmapheresis","Inclusion Criteria:\n\n* Age ≥ 18 years at enrollment\n* Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks\n* Planned follow-up at the transplant center for a minimum of one-year.\n* Patient able and willing to comply with the study visit schedule, study procedures, and study requirements.\n\nExclusion Criteria:\n\n* Recipient of a multi-organ transplant\n* History of prior solid organ transplant before the index heart transplant\n* Ongoing mechanical circulatory support or hemodynamic instability (e.g., inotrope or vasopressor therapy)\n* Ongoing need for renal replacement therapy and\u002For dialysis\n* Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression\n* Active rejection being treated with intravenous medications or plasmapheresis",[55,56],"ADULT","OLDER_ADULT",[58,75,88,103,117,131],{"facility":59,"status":7,"city":60,"state":61,"zip":62,"country":63,"contacts":64,"geoPoint":72},"Cedars-Sinai Medical Center","Los Angeles","California","90048","United States",[65,69],{"name":66,"role":67,"email":68},"Lucilla Garcia","CONTACT","lucilla.garcia@csmns.org",{"name":70,"role":71},"Jon Kobashigawa, MD","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},34.05223,-118.24368,{"facility":76,"status":7,"city":77,"state":61,"zip":78,"country":63,"contacts":79,"geoPoint":85},"Stanford University","Palo Alto","94304",[80,83],{"name":81,"role":67,"email":82},"James Pak","jamespak@stanford.edu",{"name":84,"role":71},"Kiran Khush, MD",{"lat":86,"lon":87},37.44188,-122.14302,{"facility":89,"status":7,"city":90,"state":91,"zip":92,"country":63,"contacts":93,"geoPoint":100},"Tufts Medical Center","Boston","Massachusetts","02111",[94,98],{"name":95,"role":67,"phone":96,"email":97},"Abena Adwetewa-Badu","617-636-9458","Abena.Adwetewa-Badu@tuftsmedicine.org",{"name":99,"role":71},"Jeong Hwan Kim, MD",{"lat":101,"lon":102},42.35843,-71.05977,{"facility":104,"status":7,"city":105,"state":106,"zip":107,"country":63,"contacts":108,"geoPoint":114},"Medical University of South Carolina","Charleston","South Carolina","29425",[109,112],{"name":110,"role":67,"email":111},"Melissa Amitrano","amitrano@musc.edu",{"name":113,"role":71},"Ryan Tedford, MD",{"lat":115,"lon":116},32.77632,-79.93275,{"facility":118,"status":7,"city":119,"state":120,"zip":121,"country":63,"contacts":122,"geoPoint":128},"Vanderbilt University","Nashville","Tennessee","37232",[123,126],{"name":124,"role":67,"email":125},"Lisa Slinger","Lisa.slinger@vumc.org",{"name":127,"role":71},"Kelly Schlendorf, MD",{"lat":129,"lon":130},36.16589,-86.78444,{"facility":132,"status":7,"city":133,"state":134,"zip":135,"country":63,"contacts":136,"geoPoint":142},"Baylor University Medical Center","Dallas","Texas","75246",[137,140],{"name":138,"role":67,"email":139},"Jasha Harvey","jasha.harvey@BSWHealth.org",{"name":141,"role":71},"Shelley Hall, MD",{"lat":143,"lon":144},32.78306,-96.80667,[146],{"name":147,"role":67,"phone":148,"email":149},"Palak Shah, MD","312-694-7805","optimal@northwestern.edu",[],[152,156],{"pmid":153,"type":154,"citation":155},"28940102","BACKGROUND","Shah P, Bristow MR, Port JD. MicroRNAs in Heart Failure, Cardiac Transplantation, and Myocardial Recovery: Biomarkers with Therapeutic Potential. Curr Heart Fail Rep. 2017 Dec;14(6):454-464. doi: 10.1007\u002Fs11897-017-0362-8.",{"pmid":157,"type":154,"citation":158},"35872109","Shah P, Agbor-Enoh S, Bagchi P, deFilippi CR, Mercado A, Diao G, Morales DJ, Shah KB, Najjar SS, Feller E, Hsu S, Rodrigo ME, Lewsey SC, Jang MK, Marboe C, Berry GJ, Khush KK, Valantine HA; GRAfT Investigators. Circulating microRNAs in cellular and antibody-mediated heart transplant rejection. J Heart Lung Transplant. 2022 Oct;41(10):1401-1413. doi: 10.1016\u002Fj.healun.2022.06.019. Epub 2022 Jun 28.",[],{"nct_id":4,"conditions":161,"biomarkers":164},[162,163],"Graft rejection line","Heart Failure",[],{"nct_id":4,"found":166,"summary":167,"prompt_version":177},true,{"design":168,"status":169,"heading":170,"summary":171,"follow_up":172,"word_count":173,"commitments":174,"compensation":175,"drugs_mentioned":176},"This is a multicenter observational study involving about 250 heart transplant patients. It is not a randomized or blinded study.","completed","Observational Study on MicroRNA Levels After Heart Transplant","This study is looking at how tiny molecules called microRNAs (miRs) in your blood can help doctors understand your immune system after a heart transplant. The goal is to find a way to predict if you might get an infection or if your body might reject the new heart. Researchers will collect blood samples at different times after your transplant and when you have certain medical events. They will also gather information about your health, medications, and other tests. This information will help them develop a blood test to better monitor heart transplant patients, aiming to prevent complications like infection or rejection. This is an observational study, meaning you will receive standard care, and researchers will collect data. The study is currently unclear on its recruitment status.","Participants will be followed for up to 3 years after their heart transplant to assess microRNA levels.",127,"You would participate for 36 months, with blood samples collected at specified times and during clinical events. Other data like medical history and test results will also be gathered.","Not stated in the trial record.",[],"v2"]