NCT05459181

HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)

Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 930 (estimated)
• Sponsor: CareDx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label randomized controlled two-arm interventional trial. Eligible patients starting triple maintenance therapy (tacrolimus, mycophenolate mofetil and prednisone) post-transplant will be randomized at a 1:1 ratio into the HeartCare immuno-optimization (intervention) arm or the corresponding observational (control) arm. Participants enrolled in the study will begin HeartCare testing as specified in the protocol. All centers will use their own induction regimen provided that the induction practice represents standard of care. Participants will be randomized at 4-weeks post-transplant, assuming they meet requisite clinical/laboratory/histological criteria to proceed. In the Interventional Arm, participants will begin stepwise optimization of their immunosuppression regimen based on their HeartCare, clinical DSA testing, and histology. Patient data (including diagnosis and biopsy outcomes) will be collected through an electronic data capture portal where key results will be transcribed from the hospital EMR into the portal.

Conditions

• Heart Transplant
• Immunosuppression
• Allograft

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	HeartCare	Using HeartCare platform as a tool to successfully augment immunosuppressant agents through regular surveillance allowing minimization of doses and number of agents.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-07-14
• Last updated: 2024-10-23

Regulatory

• FDA-regulated device study