Heart TransplantMOSAICNCT05459181
HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)
A study testing HeartCare in people with Heart Transplant and Immunosuppression, run by CareDx.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant, Immunosuppression, Allograft
- What is being tested?
- HeartCare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 930 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Participant is willing and able to give informed consent for participation in the trial
- In the Investigator's opinion, is able and willing to comply with all trial requirements
Who cannot join
- The participant may not enter the trial if ANY of the following apply:
- 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
- Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
Show all 19Show fewer
- Contraindication to having AlloSure or AlloMap testing
- 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)
- 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.
- Participants who are currently or have previously participated in another research trial involving an investigational immunological drug in the past 12 weeks
- 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:
- Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
- Any episodes of biopsy-proven acute rejection (ACR ≥2R or AMR*)
- Abnormal molecular profile defined as AlloSure >0.2%
- Allograft dysfunction defined as LVEF <45%
- eGFR <30mL/min
- Presence of DSA (persistence of any pre-transplant DSA or dnDSA) *AMR 1 (H+) with DSA/graft dysfunction or AMR > 2
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant
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.
Read the 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
- Being tested
- HeartCare
- Keywords
- HeartCare, Allograft loss and survival, Calcineurin inhibitors, Chronic immunosuppression, Steroid avoidance, Donor-specific antibodies, Donor-derived cell-free DNA, AlloSure, AlloMap, Gene expression profiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartCareDiagnostic test
Using HeartCare platform as a tool to successfully augment immunosuppressant agents through regular surveillance allowing minimization of doses and number of agents.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | 465 participants undergoing standard of care post-transplant surveillance |
| Intervention arm | Experimental | 465 participants undergoing HeartCare protocol surveillance Receives: Diagnostic Test: HeartCare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
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.
Measured: 24 months
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.
Measured: 12 months
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.
Measured: 24 months
EQ-5D survey performed at 12-months post-transplant to assess allograft function (safety)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 12 months
TTE imaging performed at 12-months post-transplant to assess allograft function (safety)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 12 months
EQ-5D survey performed at 24-months post-transplant to assess allograft function (safety)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 24 months
TTE imaging performed at 24-months post-transplant to assess allograft function (safety)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 24 months
Incidence of dnDSA formation at 12-months post-transplant (safety and efficacy)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 12 months
Incidence of dnDSA formation at 24-months post-transplant (safety and efficacy)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 24 months
Change in eGFR at 12-months post-transplant (efficacy)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 12 months
Change in eGFR at 24-months post-transplant (efficacy)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 24 months
Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies (efficacy)
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Measured: 24 months
Secondary outcomes (3)
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.
Measured: 6 months
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study startDec 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459181
- Sponsor's protocol ID
- SN-C-00021
- Acronym
- MOSAIC
- Status last verified
- Oct 2024
- First submitted
- 22 Jun 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant
- ClinicalTrials.gov ID
- NCT05459181
- Acronym / sponsor ID
- MOSAIC / SN-C-00021
- Conditions
- Heart Transplant, Immunosuppression, Allograft
- Keywords
- HeartCare, Allograft loss and survival, Calcineurin inhibitors, Chronic immunosuppression, Steroid avoidance, Donor-specific antibodies, Donor-derived cell-free DNA, AlloSure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 930 participants (estimated)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –465 participants undergoing standard of care post-transplant surveillance |
| Intervention arm | Experimental | Diagnostic Test: HeartCare465 participants undergoing HeartCare protocol surveillance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Participant is willing and able to give informed consent for participation in the trial
Key exclusion criteria (19 listed)
- 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
- Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and/or co-stimulatory blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartCareUsing HeartCare platform as a tool to successfully augment immunosuppressant agents through regular surveillance allowing minimization of doses and number of agents. | Diagnostic test | Intervention arm |
Primary outcome
Incidence of Allograft loss at 12-months post-transplant (safety)
Time frame: 12 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Incidence of Allograft loss at 24-months post-transplant (safety)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Total number of acute rejection episodes (ACR >2R or AMR*) at 12-months post-transplant (safety)
Time frame: 12 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Total number of acute rejection episodes (ACR >2R or AMR*) at 24-months post-transplant (safety)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
EQ-5D survey performed at 12-months post-transplant to assess allograft function (safety)
Time frame: 12 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
TTE imaging performed at 12-months post-transplant to assess allograft function (safety)
Time frame: 12 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
EQ-5D survey performed at 24-months post-transplant to assess allograft function (safety)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
TTE imaging performed at 24-months post-transplant to assess allograft function (safety)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Incidence of dnDSA formation at 12-months post-transplant (safety and efficacy)
Time frame: 12 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Incidence of dnDSA formation at 24-months post-transplant (safety and efficacy)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Change in eGFR at 12-months post-transplant (efficacy)
Time frame: 12 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Change in eGFR at 24-months post-transplant (efficacy)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
Total number of biopsies performed post-transplant, including both surveillance and clinically indicated biopsies (efficacy)
Time frame: 24 months
Demonstrate the safety and efficacy of HeartCare as a tool to successfully optimize immunosuppressant agents using regular surveillance for safe drug minimization.
3 secondary outcomes
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.
Time frame: 6 months
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).
Time frame: 24 months
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.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Related trials for Heart Transplant
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing HeartCare in people with Heart Transplant and Immunosuppression, run by CareDx.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Thomas (415-780-2752, athomas@caredx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Allograft loss at 12-months post-transplant (safety) (time frame: 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.