[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100474536":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":12,"responsibleParty":31,"collaborators":12,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":12,"enrollmentInfo":43,"targetDuration":12,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":54,"overallStatus":64,"whyStopped":12,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":12},{"fullName":5,"class":6},"CareDx","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm","NO_INTERVENTION","465 participants undergoing standard of care post-transplant surveillance",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention arm","EXPERIMENTAL","465 participants undergoing HeartCare protocol surveillance",[18],"Diagnostic Test: HeartCare",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DIAGNOSTIC_TEST","HeartCare","Using HeartCare platform as a tool to successfully augment immunosuppressant agents through regular surveillance allowing minimization of doses and number of agents.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Anna Thomas","CONTACT","415-780-2752","athomas@caredx.com",{"type":32,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100474536","heartcare-immuno-optimization-in-cardiac-allografts-mosaic-100474536",false,"NCT05459181","HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)","Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant","MOSAIC","Inclusion Criteria:\n\n1. Heart transplant recipients \\\u003C2 weeks post-transplant\n2. Patients aged 18 years or older\n3. Planned post-transplant maintenance immunosuppression regimen consisting of prednisolone, tacrolimus and mycophenolate\n4. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter\n5. Participant is willing and able to give informed consent for participation in the trial\n6. In the Investigator's opinion, is able and willing to comply with all trial requirements\n\nExclusion Criteria:\n\nThe participant may not enter the trial if ANY of the following apply:\n\n1. Multi-visceral transplant recipients\n2. Female participant who is pregnant, lactating or planning pregnancy during the trial\n3. Heart transplant recipients undergoing desensitization protocols prior to transplant based off high immunological risk profiles (determined by treating clinician)\n4. Chronic oral steroid use for any reason that cannot be tapered off and discontinued\n5. Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n6. Contraindication to having AlloSure or AlloMap testing\n7. Participant with life expectancy of less than 6 months or is inappropriate for immuno-optimization (including those patients at increased risk of primary disease recurrence w\u002F reduction in post-transplant immunosuppression)\n8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. This includes clinical events that would significantly impact post-transplant immunosuppression such as major infectious complications or significant rejection episodes within the first month post-transplant.\n9. Participants who are currently or have previously participated in another research trial involving an investigational immunological drug in the past 12 weeks\n10. Any condition that would preclude protocol biopsies\n\nRandomization Criteria (assessed at Week 4)\n\nThe participant may not proceed with randomization if ANY of the following apply at Week 4 post-transplant:\n\n1. Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n2. Any episodes of biopsy-proven acute rejection (ACR ≥2R or AMR\\*)\n3. Abnormal molecular profile defined as AlloSure \\>0.2%\n4. Allograft dysfunction defined as LVEF \\\u003C45%\n5. eGFR \\\u003C30mL\u002Fmin\n6. Presence of DSA (persistence of any pre-transplant DSA or dnDSA) \\*AMR 1 (H+) with DSA\u002Fgraft dysfunction or AMR \\> 2","ALL","18 Years",{"count":44,"type":45},930,"ESTIMATED","INTERVENTIONAL",[48],"NA","This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor heart), donor-derived cell-free DNA (AlloSure), and gene expression profiling (AlloMap). Eligible participants will be randomized in a 1:1 ratio into the HeartCare immune-optimization (intervention) arm or the corresponding observational (control) arm. AlloSure and AlloMap are the components of the HeartCare panel developed by CareDx.",[51,52,53],"Heart Transplant","Immunosuppression","Allograft",[22,55,56,57,58,59,60,61,62,63],"Allograft loss and survival","Calcineurin inhibitors","Chronic immunosuppression","Steroid avoidance","Donor-specific antibodies","Donor-derived cell-free DNA","AlloSure","AlloMap","Gene expression profiling","NOT_YET_RECRUITING","2024-10-21",{"date":67,"type":68},"2024-10-23","ACTUAL",{"date":70,"type":45},"2025-12",{"date":72,"type":45},"2026-09",{"name":5,"class":6}]