Heart Transplant RejectionMERITNCT07905599
Molecular Evidence of Rejection Intervention Trial
A study testing Prednisone in people with Heart Transplant Rejection, run by CareDx.
Trial summary
MERIT is a double-blind, multi-center, placebo-controlled, randomized clinical trial. Heart transplant recipients with dual-positive GEP/dd-cfDNA assays with a corresponding negative biopsy between 2 months and 2 years post-transplant will be randomized to treatment with either high-dose oral steroids or placebo, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Rejection
- What is being tested?
- Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient has provided informed consent
- Age ≥18 years old at the time of consent
- Heart transplant recipient between 2 months to 2 years post-transplant
- Simultaneous dual-positive GEP/dd-cfDNA result, defined as both a dd-cfDNA level ≥0.20% AND one of the following:
- a GEP score ≥30 (if 55-180 days post-transplant)
- a GEP score ≥34 (if ≥181 days post-transplant)
Show all 15Show fewer
- An endomyocardial biopsy (EMB) showing no rejection [(0R or 1R) and pAMR0] AND both of the following:
- Performed on the same day or up to 10 calendar days after the simultaneous dual-positive GEP/dd-cfDNA draw.
- No intention to treat the subject empirically for ACR or AMR based on other clinical features, including clinically relevant DSA
- If the closest GEP/dd-cfDNA result prior to screening was also dual positive, both of the following must be true:
- GEP score OR dd-cfDNA level has increased from previous value
- Neither GEP score nor dd-cfDNA level have decreased from previous value
- Randomization within 14 calendar days of the simultaneous dual positive GEP/dd-cfDNA draw
- All patients of childbearing potential must have a negative pregnancy test prior to randomization. Use of contraception must be followed per site standard clinical protocol.
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Multiorgan or bone marrow transplant recipient
- On an organ transplant waitlist at the time of screening
- In-patient at the time of study screening
- Presence of an active infection being treated with an antibiotic, antifungal, and/or antiviral or malignancy
- Random capillary blood glucose of >180 mg/dL on day of enrollment
- Enrollment in another interventional study or exposed to experimental drug in the last 30 days
Show all 13Show fewer
- LVEF <55% on the most recent echocardiogram
- Most recent EMB before screening showing ACR (≥2R) and/or AMR (≥pAMR1)
- Intent to transfer heart transplant care to another center in the 12-months after randomization
- Patient who, in the opinion of the treating provider or Investigator, is not an appropriate candidate for study participation due to safety concerns, medical judgment, or other clinical considerations.
- Patient receiving steroids at a dose equivalent to ≥25 mg/day
- Clinical or hemodynamic concern for rejection-related heart failure, as determined by the treating clinician
- Patient receiving granulocyte colony stimulating factor (GCSF) within the past 30 days
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Srey Yin contact
About this study
Official title: Molecular Evidence of Rejection Intervention Trial (MERIT)
MERIT is a double-blind, multi-center, placebo-controlled, randomized clinical trial. Heart transplant recipients with dual-positive GEP/dd-cfDNA assays with a corresponding negative biopsy between 2 months and 2 years post-transplant will be randomized to treatment with either high-dose oral steroids or placebo, in addition to standard of care therapy.
Read the detailed description
This study is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolling approximately 200 adult heart transplant recipients across up to 20 transplant centers in the United States and Canada. Eligible participants are adults (≥18 years) between 2 months and 2 years post-heart transplant who have simultaneous dual-positive molecular testing-defined as both an elevated gene expression profiling (GEP) and elevated donor derived cell-free DNA (dd-cfDNA) result-paired with an endomyocardial biopsy showing no evidence of acute rejection (ISHLT grade 0R or 1R and pAMR0).
Participants will be randomized in a 1:1 ratio to receive either high-dose oral prednisone (100 mg daily for 3 consecutive days) or matched placebo, in addition to standard of care therapy. Treatment assignment will be blinded to participants, investigators, and study personnel.
The primary objective is to determine whether high-dose steroid therapy improves clinical outcomes at 180 days following randomization.
Participants will be followed for 12 months after randomization, with scheduled assessments at 28 days, 180 days, and 365 days, including clinical evaluation, laboratory testing, echocardiography, and molecular biomarker measurements.
By evaluating whether early intervention based on molecular evidence of graft injury can improve outcomes, this study aims to inform clinical decision-making and potentially establish a new treatment paradigm for heart transplant recipients with molecular evidence of allograft injury that is not detected by biopsy.
- Conditions
- Heart Transplant Rejection
- Being tested
- Prednisone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
100mg per day for three days following randomization
PlaceboDrug
Matched placebo in same patient population.
| Study group | Role | What they receive |
|---|---|---|
| High Dose Prednisone | Active comparator | Three days, 100mg of prednisone Receives: Drug: Prednisone |
| Placebo | Placebo comparator | Matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
A hierarchical composite outcome of time to death or re-transplantation, time to graft dysfunction (LVEF <50%), time to ACR 2R higher and/or pAMR1 or higher, hospitalization (yes/no), dd-cfDNA <0.20% (yes/no), and percent reduction in dd-cfDNA from randomization.
Measured: Assessed at 180 (± 14) days post-randomization
Secondary outcomes (2)
Secondary Endpoint
A hierarchical composite outcome of time to death or re-transplantation, time to graft dysfunction (LVEF <50%), time to ACR 2R higher and/or pAMR1 or higher, hospitalization (yes/no), dd-cfDNA <0.20% (yes/no), and percent reduction in dd-cfDNA from randomization.
Measured: Assessed at 28 (±7) days post-randomization
Safety Endpoint
Incidence of infection requiring treatment with antibiotics, antivirals, and/or antifungals, hyperglycemia requiring an unplanned clinic visit, emergency room visit or hospitalization, and bone fracture or avascular necrosis.
Measured: Randomization through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Heart Transplant RejectionStudies 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
- Model description
- Randomized, double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kiran Khush, MD, Principal investigator, Stanford UniversityNir Uriel, MD, MSc, FACC, Principal investigator, Columbia University Irving Medical Center, Weill Cornell Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905599
- Sponsor's protocol ID
- CDNAHE2502
- Acronym
- MERIT
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gregson J, Taylor D, Owen R, Collier T, J Cohen D, Pocock S. Hierarchical Composite Outcomes and Win Ratio Methods in Cardiovascular Trials: A Review and Consequent Guidance. Circulation. 2025 Jun 3;151(22):1606-1619. doi: 10.1161/CIRCULATIONAHA.124.070251. Epub 2025 Jun 2.
PubMed 40455842Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
PubMed 21900289Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034. No abstract available.
PubMed 20643330Teuteberg J, Patel S, Baran DA, Shah P, Sayer G, Nguyen AB, Ravichandran A, Hall S, Pinney S, DePasquale E, Raval N, Kobulnik J, Fan CS, Oreschak K, Wang S, Khush KK, Uriel N. Multimodal molecular testing provides prognostic value for heart transplant recipients. J Heart Lung Transplant. 2026 Mar;45(3):388-400. doi: 10.1016/j.healun.2025.11.013. Epub 2025 Nov 24.
PubMed 41297735Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.
PubMed 26452346Deng MC, Elashoff B, Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Shahzad K, Hiller D, Yee J, Valantine HA; IMAGE Study Group. Utility of gene expression profiling score variability to predict clinical events in heart transplant recipients. Transplantation. 2014 Mar 27;97(6):708-14. doi: 10.1097/01.TP.0000443897.29951.cf.
PubMed 24637869Mehta A, Goldberg J, Bagchi P, Marboe C, Shah KB, Najjar SS, Hsu S, Rodrigo ME, Jang MK, Cochrane A, Tchoukina IF, Kong H, Lohmar BJ, Mcnair E, Valantine HA, Agbor-Enoh S, Berry GJ, Shah P. Pathologist interrater reliability and clinical implications of elevated donor-derived cell-free DNA beyond heart transplant rejection, on behalf of the GRAfT investigators. J Heart Lung Transplant. 2025 May;44(5):803-812. doi: 10.1016/j.healun.2024.10.006. Epub 2024 Oct 17.
PubMed 39424014Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.
PubMed 26746629Khush K, Hall S, Kao A, Raval N, Dhingra R, Shah P, Bellumkonda L, Ravichandran A, Van Bakel A, Uriel N, Patel S, Pinney S, DePasquale E, Baran DA, Pinney K, Oreschak K, Kobulnik J, Shen L, Teuteberg J. Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry. J Heart Lung Transplant. 2024 Sep;43(9):1409-1421. doi: 10.1016/j.healun.2024.05.003. Epub 2024 May 15.
PubMed 38759766Khush KK, Patel J, Pinney S, Kao A, Alharethi R, DePasquale E, Ewald G, Berman P, Kanwar M, Hiller D, Yee JP, Woodward RN, Hall S, Kobashigawa J. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: A prospective multicenter study. Am J Transplant. 2019 Oct;19(10):2889-2899. doi: 10.1111/ajt.15339. Epub 2019 Apr 8.
PubMed 30835940Deng MC, Eisen HJ, Mehra MR, Billingham M, Marboe CC, Berry G, Kobashigawa J, Johnson FL, Starling RC, Murali S, Pauly DF, Baron H, Wohlgemuth JG, Woodward RN, Klingler TM, Walther D, Lal PG, Rosenberg S, Hunt S; CARGO Investigators. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant. 2006 Jan;6(1):150-60. doi: 10.1111/j.1600-6143.2005.01175.x.
PubMed 16433769Velleca A, Shullo MA, Dhital K, Azeka E, Colvin M, DePasquale E, Farrero M, Garcia-Guereta L, Jamero G, Khush K, Lavee J, Pouch S, Patel J, Michaud CJ, Shullo MA, Schubert S, Angelini A, Carlos L, Mirabet S, Patel J, Pham M, Urschel S, Kim KH, Miyamoto S, Chih S, Daly K, Grossi P, Jennings DL, Kim IC, Lim HS, Miller T, Potena L, Velleca A, Eisen H, Bellumkonda L, Danziger-Isakov L, Dobbels F, Harkess M, Kim D, Lyster H, Peled Y, Reinhardt Z. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023 May;42(5):e1-e141. doi: 10.1016/j.healun.2022.10.015. Epub 2022 Dec 20. No abstract available.
PubMed 37080658Singh TP, Hsich E, Cherikh WS, Perch M, Hayes D Jr, Lewis A, Dellgren G, Cogswell R; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: 2025 Annual Report of Heart and Lung Transplantation. J Heart Lung Transplant. 2025 Dec;44(12):1857-1873. doi: 10.1016/j.healun.2025.04.014. Epub 2025 Apr 27. No abstract available.
PubMed 40300677
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Evidence of Rejection Intervention Trial (MERIT)
- ClinicalTrials.gov ID
- NCT07905599
- Acronym / sponsor ID
- MERIT / CDNAHE2502
- Conditions
- Heart Transplant Rejection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CareDxIndustry (pharma, biotech, devices)
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 Oct 2026 (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.
MERIT is a double-blind, multi-center, placebo-controlled, randomized clinical trial. Heart transplant recipients with dual-positive GEP/dd-cfDNA assays with a corresponding negative biopsy between 2 months and 2 years post-transplant will be randomized to treatment with either high-dose oral steroids or placebo, in addition to standard of care therapy.
Detailed description
This study is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial enrolling approximately 200 adult heart transplant recipients across up to 20 transplant centers in the United States and Canada. Eligible participants are adults (≥18 years) between 2 months and 2 years post-heart transplant who have simultaneous dual-positive molecular testing-defined as both an elevated gene expression profiling (GEP) and elevated donor derived cell-free DNA (dd-cfDNA) result-paired with an endomyocardial biopsy showing no evidence of acute rejection (ISHLT grade 0R or 1R and pAMR0).
Participants will be randomized in a 1:1 ratio to receive either high-dose oral prednisone (100 mg daily for 3 consecutive days) or matched placebo, in addition to standard of care therapy. Treatment assignment will be blinded to participants, investigators, and study personnel.
The primary objective is to determine whether high-dose steroid therapy improves clinical outcomes at 180 days following randomization.
Participants will be followed for 12 months after randomization, with scheduled assessments at 28 days, 180 days, and 365 days, including clinical evaluation, laboratory testing, echocardiography, and molecular biomarker measurements.
By evaluating whether early intervention based on molecular evidence of graft injury can improve outcomes, this study aims to inform clinical decision-making and potentially establish a new treatment paradigm for heart transplant recipients with molecular evidence of allograft injury that is not detected by biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| High Dose Prednisone | Active comparator | Drug: PrednisoneThree days, 100mg of prednisone |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The patient has provided informed consent
- Age ≥18 years old at the time of consent
- Heart transplant recipient between 2 months to 2 years post-transplant
- Simultaneous dual-positive GEP/dd-cfDNA result, defined as both a dd-cfDNA level ≥0.20% AND one of the following:
- An endomyocardial biopsy (EMB) showing no rejection [(0R or 1R) and pAMR0] AND both of the following:
Key exclusion criteria (13 listed)
- Multiorgan or bone marrow transplant recipient
- On an organ transplant waitlist at the time of screening
- In-patient at the time of study screening
- Presence of an active infection being treated with an antibiotic, antifungal, and/or antiviral or malignancy
- Random capillary blood glucose of >180 mg/dL on day of enrollment
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 |
|---|---|---|
| Prednisone100mg per day for three days following randomization | Drug | High Dose Prednisone |
| PlaceboMatched placebo in same patient population. | Drug | Placebo |
Primary outcome
Primary Endpoint
Time frame: Assessed at 180 (± 14) days post-randomization
A hierarchical composite outcome of time to death or re-transplantation, time to graft dysfunction (LVEF <50%), time to ACR 2R higher and/or pAMR1 or higher, hospitalization (yes/no), dd-cfDNA <0.20% (yes/no), and percent reduction in dd-cfDNA from randomization.
2 secondary outcomes
Secondary Endpoint
Time frame: Assessed at 28 (±7) days post-randomization
Safety Endpoint
Time frame: Randomization through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 40455842Gregson J, Taylor D, Owen R, Collier T, J Cohen D, Pocock S. Hierarchical Composite Outcomes and Win Ratio Methods in Cardiovascular Trials: A Review and Consequent Guidance. Circulation. 2025 Jun 3;151(22):1606-1619. doi: 10.1161/CIRCULATIONAHA.124.070251. Epub 2025 Jun 2.
- Background: PubMed 21900289Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
- Background: PubMed 20643330Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034. No abstract available.
- Background: PubMed 41297735Teuteberg J, Patel S, Baran DA, Shah P, Sayer G, Nguyen AB, Ravichandran A, Hall S, Pinney S, DePasquale E, Raval N, Kobulnik J, Fan CS, Oreschak K, Wang S, Khush KK, Uriel N. Multimodal molecular testing provides prognostic value for heart transplant recipients. J Heart Lung Transplant. 2026 Mar;45(3):388-400. doi: 10.1016/j.healun.2025.11.013. Epub 2025 Nov 24.
- Background: PubMed 26452346Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Deng M, Leprince P, Hiller D, Eubank L, Deljkich E, Yee JP, Vanhaecke J. Performance of gene-expression profiling test score variability to predict future clinical events in heart transplant recipients. BMC Cardiovasc Disord. 2015 Oct 9;15:120. doi: 10.1186/s12872-015-0106-1.
- Background: PubMed 24637869Deng MC, Elashoff B, Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Shahzad K, Hiller D, Yee J, Valantine HA; IMAGE Study Group. Utility of gene expression profiling score variability to predict clinical events in heart transplant recipients. Transplantation. 2014 Mar 27;97(6):708-14. doi: 10.1097/01.TP.0000443897.29951.cf.
- Background: PubMed 39424014Mehta A, Goldberg J, Bagchi P, Marboe C, Shah KB, Najjar SS, Hsu S, Rodrigo ME, Jang MK, Cochrane A, Tchoukina IF, Kong H, Lohmar BJ, Mcnair E, Valantine HA, Agbor-Enoh S, Berry GJ, Shah P. Pathologist interrater reliability and clinical implications of elevated donor-derived cell-free DNA beyond heart transplant rejection, on behalf of the GRAfT investigators. J Heart Lung Transplant. 2025 May;44(5):803-812. doi: 10.1016/j.healun.2024.10.006. Epub 2024 Oct 17.
- Background: PubMed 26746629Crespo-Leiro MG, Stypmann J, Schulz U, Zuckermann A, Mohacsi P, Bara C, Ross H, Parameshwar J, Zakliczynski M, Fiocchi R, Hoefer D, Colvin M, Deng MC, Leprince P, Elashoff B, Yee JP, Vanhaecke J. Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II. Eur Heart J. 2016 Sep 1;37(33):2591-601. doi: 10.1093/eurheartj/ehv682. Epub 2016 Jan 7.
- Background: PubMed 38759766Khush K, Hall S, Kao A, Raval N, Dhingra R, Shah P, Bellumkonda L, Ravichandran A, Van Bakel A, Uriel N, Patel S, Pinney S, DePasquale E, Baran DA, Pinney K, Oreschak K, Kobulnik J, Shen L, Teuteberg J. Surveillance with dual noninvasive testing for acute cellular rejection after heart transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry. J Heart Lung Transplant. 2024 Sep;43(9):1409-1421. doi: 10.1016/j.healun.2024.05.003. Epub 2024 May 15.
- Background: PubMed 30835940Khush KK, Patel J, Pinney S, Kao A, Alharethi R, DePasquale E, Ewald G, Berman P, Kanwar M, Hiller D, Yee JP, Woodward RN, Hall S, Kobashigawa J. Noninvasive detection of graft injury after heart transplant using donor-derived cell-free DNA: A prospective multicenter study. Am J Transplant. 2019 Oct;19(10):2889-2899. doi: 10.1111/ajt.15339. Epub 2019 Apr 8.
- Background: PubMed 16433769Deng MC, Eisen HJ, Mehra MR, Billingham M, Marboe CC, Berry G, Kobashigawa J, Johnson FL, Starling RC, Murali S, Pauly DF, Baron H, Wohlgemuth JG, Woodward RN, Klingler TM, Walther D, Lal PG, Rosenberg S, Hunt S; CARGO Investigators. Noninvasive discrimination of rejection in cardiac allograft recipients using gene expression profiling. Am J Transplant. 2006 Jan;6(1):150-60. doi: 10.1111/j.1600-6143.2005.01175.x.
- Background: PubMed 37080658Velleca A, Shullo MA, Dhital K, Azeka E, Colvin M, DePasquale E, Farrero M, Garcia-Guereta L, Jamero G, Khush K, Lavee J, Pouch S, Patel J, Michaud CJ, Shullo MA, Schubert S, Angelini A, Carlos L, Mirabet S, Patel J, Pham M, Urschel S, Kim KH, Miyamoto S, Chih S, Daly K, Grossi P, Jennings DL, Kim IC, Lim HS, Miller T, Potena L, Velleca A, Eisen H, Bellumkonda L, Danziger-Isakov L, Dobbels F, Harkess M, Kim D, Lyster H, Peled Y, Reinhardt Z. The International Society for Heart and Lung Transplantation (ISHLT) guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2023 May;42(5):e1-e141. doi: 10.1016/j.healun.2022.10.015. Epub 2022 Dec 20. No abstract available.
Related trials for Heart Transplant Rejection
Not yet recruiting
Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
Heart Transplantation
Enrolling by invitationObservational study
Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
Heart Transplantation
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
RecruitingObservational study
Trifecta-Heart cfDNA-MMDx Study
Heart Transplant Rejection
RecruitingPhase 2/3
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
CMV Viremia, Heart Transplant Infection
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.
Srey Yin contact
Kiran Khush, MD principal investigator
Stanford University
Nir Uriel, MD, MSc, FACC principal investigator
Columbia University Irving Medical Center, Weill Cornell Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Prednisone in people with Heart Transplant Rejection, 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 15 inclusion and 13 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Kennedy ((415) 287-2300 ext. 5929, ekennedy@caredx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: Assessed at 180 (± 14) days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07905599, which also lists 13 linked publications.
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 29 Oct 2026.