Health TrialsbyHealthPanel

HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)

ConditionsHeart TransplantImmunosuppressionAllograft
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCareDx

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Heart transplant recipients <2 weeks post-transplant

Patients aged 18 years or older

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

Disqualifiers

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)

Chronic oral steroid use for any reason that cannot be tapered off and discontinued

Trial design

Design model

Parallel

Treatments tested in this trial

  • HeartCare

    Diagnostic test

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

Treatment groups

930 Participants
are divided into 2 treatment groups
Group A: Control armNo intervention 0 interventions
Group B: Intervention armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Allograft loss at 12-months post-transplant (safety)

Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.

Time frame
12 months
2

Incidence of Allograft loss at 24-months post-transplant (safety)

Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.

Time frame
24 months
3

Total number of acute rejection episodes (ACR >2R or AMR*) at 12-months post-transplant (safety)

Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.

Time frame
12 months
4

Total number of acute rejection episodes (ACR >2R or AMR*) at 24-months post-transplant (safety)

Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.

Time frame
24 months

Secondary outcomes

1

Histological assessment of tissue biopsy with paired AlloSure dd-cfDNA and AlloMap GEP results (HeartCare) - performed both 'For Cause' and 'Surveillance' using standard biopsy assessment.

Identify correlation between HeartCare and histopathological allograft rejection based on all clinical biopsies.

Time frame
6 months
2

Association between AlloSure dd-cfDNA and AlloMap GEP (HeartCare) results with successful immuno-optimization, longitudinal clinical/laboratory parameters (dnDSA), and histologic data (allograft rejection, CAV).

Establish temporal relationships between HeartCare and allograft injury patterns such as dnDSA formation, allograft rejection and CAV.

Time frame
24 months
3

Data collection from patient medical record, to capture episodes of infection, viral PCR results, changes in immunosuppression and treatment of rejection, as well as all adverse advents.

Assessment of all medical events throughout the duration of the study.

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CareDx

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: