HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
← catalyst calendarNCT05459181 · readout ≤ 42 d
Sponsored by CareDx (industry) · CDNA — their whole pipeline →.
Phase
Not applicable
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
930estimated
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Dec 2025 | estimated | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-07-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2024-10-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Heart Transplant
- Immunosuppression
- Allograft
Intervention
- Diagnostic test: HeartCare
Primary outcomes
what the primary-completion date above is the date OFIncidence of Allograft loss at 12-months post-transplant (safety)
measured 12 months
Incidence of Allograft loss at 24-months post-transplant (safety)
measured 24 months
Total number of acute rejection episodes (ACR >2R or AMR*) at 12-months post-transplant (safety)
measured 12 months
Total number of acute rejection episodes (ACR >2R or AMR*) at 24-months post-transplant (safety)
measured 24 months
EQ-5D survey performed at 12-months post-transplant to assess allograft function (safety)
measured 12 months
TTE imaging performed at 12-months post-transplant to assess allograft function (safety)
measured 12 months
EQ-5D survey performed at 24-months post-transplant to assess allograft function (safety)
measured 24 months
TTE imaging performed at 24-months post-transplant to assess allograft function (safety)
measured 24 months
Incidence of dnDSA formation at 12-months post-transplant (safety and efficacy)
measured 12 months
Incidence of dnDSA formation at 24-months post-transplant (safety and efficacy)
measured 24 months
Change in eGFR at 12-months post-transplant (efficacy)
measured 12 months
Change in eGFR at 24-months post-transplant (efficacy)
measured 24 months
Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies (efficacy)
measured 24 months
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