HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)

Exclusion Criteria

• •The participant may not enter the trial if ANY of the following apply:
• •1. Multi-visceral transplant recipients
• •2. Female participant who is pregnant, lactating or planning pregnancy during the trial
• •3. Heart transplant recipients undergoing desensitization protocols prior to transplant based off high immunological risk profiles (determined by treating clinician)
• •4. Chronic oral steroid use for any reason that cannot be tapered off and discontinued
• •5. Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
• •6. Contraindication to having AlloSure or AlloMap testing
• •7. 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)
• •8. 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.
• •9. Participants who are currently or have previously participated in another research trial involving an investigational immunological drug in the past 12 weeks
• •10. Any condition that would preclude protocol biopsies
• •Randomization Criteria (assessed at Week 4)
• •The participant may not proceed with randomization if ANY of the following apply at Week 4 post-transplant:
• •1. Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
• •2. Any episodes of biopsy-proven acute rejection (ACR ≥2R or AMR\*)
• •3. Abnormal molecular profile defined as AlloSure \>0.2%
• •4. Allograft dysfunction defined as LVEF \<45%
• •5. eGFR \<30mL/min
• •6. Presence of DSA (persistence of any pre-transplant DSA or dnDSA) \*AMR 1 (H+) with DSA/graft dysfunction or AMR \> 2