HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
930 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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
✓. Participant is willing and able to give informed consent for participation in the trial
✓. In the Investigator's opinion, is able and willing to comply with all trial requirements
Exclusion criteria
✕. 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)
What they're measuring
1
Incidence of Allograft loss at 12-months post-transplant (safety)
Timeframe: 12 months
2
Incidence of Allograft loss at 24-months post-transplant (safety)
Timeframe: 24 months
3
Total number of acute rejection episodes (ACR >2R or AMR*) at 12-months post-transplant (safety)
Timeframe: 12 months
4
Total number of acute rejection episodes (ACR >2R or AMR*) at 24-months post-transplant (safety)
Timeframe: 24 months
5
EQ-5D survey performed at 12-months post-transplant to assess allograft function (safety)
Timeframe: 12 months
6
TTE imaging performed at 12-months post-transplant to assess allograft function (safety)
Timeframe: 12 months
7
EQ-5D survey performed at 24-months post-transplant to assess allograft function (safety)
Timeframe: 24 months
8
TTE imaging performed at 24-months post-transplant to assess allograft function (safety)
✕. Contraindication to having AlloSure or AlloMap testing
✕. 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/ reduction in post-transplant immunosuppression)
✕. 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.
Timeframe: 24 months
9
Incidence of dnDSA formation at 12-months post-transplant (safety and efficacy)
Timeframe: 12 months
10
Incidence of dnDSA formation at 24-months post-transplant (safety and efficacy)
Timeframe: 24 months
11
Change in eGFR at 12-months post-transplant (efficacy)
Timeframe: 12 months
12
Change in eGFR at 24-months post-transplant (efficacy)
Timeframe: 24 months
13
Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies (efficacy)