HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCareDx
About this trial
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.
Eligibility criteria
Qualifiers
Heart transplant recipients <2 weeks post-transplant
Patients aged 18 years or older
Planned post-transplant maintenance immunosuppression regimen consisting of prednisolone, tacrolimus and mycophenolate
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
Disqualifiers
Multi-visceral transplant recipients
Female participant who is pregnant, lactating or planning pregnancy during the trial
Heart transplant recipients undergoing desensitization protocols prior to transplant based off high immunological risk profiles (determined by treating clinician)
Chronic oral steroid use for any reason that cannot be tapered off and discontinued
Trial design
Treatments tested in this trial
- HeartCare
Treatment groups
930 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov