HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)

Launched by CAREDX · Jul 12, 2022

Keywords

ClinConnect Summary

The HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC) trial is a research study designed to help patients who have recently received a heart transplant. The main goal of the trial is to find out if patients who are at low risk of rejection can safely lower their doses of immunosuppressive medications after their transplant. These medications help prevent the body from rejecting the new heart, but they can have side effects. The study will use a combination of tests, including blood tests and tissue samples, to monitor the patients' health and immune response.

To be eligible for this study, participants must be at least 18 years old and have received a heart transplant within the last two weeks. They should be starting a specific type of immunosuppressive treatment and must be able to provide informed consent to participate. Participants will be placed in one of two groups: one will follow the new immune-optimization plan, while the other will continue with standard care. Throughout the study, participants can expect close monitoring of their health and may have to follow specific requirements related to their medications. This trial is important because it could lead to safer and more effective management strategies for heart transplant patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Heart transplant recipients \<2 weeks post-transplant
• • 2. Patients aged 18 years or older
• • 3. Planned post-transplant maintenance immunosuppression regimen consisting of prednisolone, tacrolimus and mycophenolate
• • 4. 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
• • 5. Participant is willing and able to give informed consent for participation in the trial
• • 6. In the Investigator's opinion, is able and willing to comply with all trial requirements
• 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