Heart Transplant RejectionNCT04707872
Trifecta-Heart cfDNA-MMDx Study
An observational study of Heart Transplant Rejection, run by University of Alberta at 12 sites in 7 countries.
Trial summary
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Transplant Rejection
- What is being tested?
- MMDx diagnostic test, Prospera and HLA antibody
- How many people
- 300 participants
- Where
- 12 sitesin 7 countries
- Study dates
- 1 Jun 2021to Jul 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications or surveillance (protocol) biopsy.
Who may be able to join
- All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study.
- Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent.
Who cannot join
- Patients will be excluded from the study if they decline participation
- Are unable to give informed consent.
- Recipients of multiple organs.
Trial locations and contacts
12 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 7 countries
United States6 sites, 6 recruiting
- Recruiting
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute
Dallas, Texas, 75246
Aayla K Jamil, MBBS, Aayla.Jamil@BSWHealth.org
Shelley Hall, MD
- Recruiting
Baptist Health Institute for Research and Innovation
Little Rock, Arkansas, 72205
Victoria McIntosh Marren, victoria.mcintosh@baptist-health.org
Patrick Campbell, MD
- Recruiting
Cardiovascular Medicine, University of Utah Health
Salt Lake City, Utah, 84132
Jennifer Hong, Jennifer.Hong@hsc.utah.edu
Josef Stehlik, MD, PhD
- Recruiting
Tampa General Hospital, 409 Bayshore Blvd.
Tampa, Florida, 33606
Kristyn Kuzianik, kkuzianik@tgh.org
Benjamin Mackie, MD
- Recruiting
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL
The Bronx, New York, 10467
Renae Robinson, rerobins@montefiore.org
Brandon Johnson, brajohnson@montefiore.org
- Recruiting
Columbia University Medical Center, Columbia Interventional Cardiovascular Care
West New York, New Jersey, 10032
Maria Alejandra Muñoz Cifuentes, mam2649@cumc.columbia.edu
Gabriel Sayer, MD
Australia1 site, 1 recruiting
- Not yet recruiting
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute
Darlinghurst, NSW 2010
Carmen Herrera, MD, peter.macdonal@svha.org.au
Peter MacDonald, MD
Canada1 site, 1 recruiting
- Recruiting
Division of Cardiology, University of Alberta
Edmonton, Alberta, T6G 2R7
Daniel Kim, MD, dk@ualberta.ca
Daniel Kim, MD
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9
Prague, 140 21
Tereza Novakowa, novt@ikem.cz
Vojtech Melenovsky, MD PhD
Italy1 site, 1 recruiting
- Not yet recruiting
Heart Failure and Heart Transplant Unit, University of Bologna
Bologna, 40138
Laura Borgese, laura.borgese@gmail.com
Luciano Potena, MD
Poland1 site, 1 recruiting
- Recruiting
Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu
Zabrze, 41-800
Agnieszka Kuczaj, MD PhD, agnieszka.kuczaj@gmail.com
Piotr Przybylowski, Professor
Spain1 site, 1 recruiting
- Not yet recruiting
Advanced Heart Failure Transplant Unit
A Coruña
Zulaika Grille Cancela, Zulaika.grille.cancela@sergas.es
Maria G Crespo-Leiro, MD
About this study
Official title: Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.
Read the detailed description
The current standard for assessment of rejection in heart transplants is an endomyocardial biopsy (EMB) interpreted by histology according to ISHLT guidelines. This has considerable error rates, many due to the high disagreement among pathologists in assessing lesions and diagnoses. To address the unmet need for precision and accuracy, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx), which uses microarrays to define the global gene expression features of rejection and injury. Now a new screening test is being introduced: the monitoring of donor-derived cell-free DNA (DD-cfDNA) released in the blood by the heart during rejection. The Natera Inc DD-cfDNA Prospera® test is based on the massively multiplex polymerase chain reaction that targets 13,392 single nucleotide polymorphisms and targeted sequences are quantified by Next Generation Sequencing. The Prospera® test has been done on kidney transplant recipients and detected "active rejection" and differentiated it from borderline rejection and no rejection. However, Prospera® test was not examined (the DD-cfDNA results) in heart transplant recipients. DD-cf-DNA test for heart transplants must now be calibrated against MMDx that is based on global gene expression, the new standard for biopsy interpretation. The present study will calibrate centrally measured (Natera Inc) DD-cfDNA levels obtained at the time of an indication or protocol biopsy against the MMDx measurements of T cell-mediated rejection (TCMR), antibody-mediated rejection (ABMR) and early and late tissue injury. The present study will compare DD-cfDNA and MMDx in 300 prospectively collected biopsies for clinical indications and protocol, and accompanying 600 blood samples, to calibrate the DD-cfDNA (Natera Inc.) levels against the MMDx biopsy diagnoses of TCMR, ABMR (and its stages), and acute (early) and chronic (late) injury, , as well as central assessment of HLA antibody (One Lambda) in 300 blood samples, interpreted centrally as donor specific antibody (DSA) based on the tissue typing results. Trifecta-Heart collected 718 biopsies, 709 cfDNA samples and 706 One Lambda samples so far. Due to a considerable interest from participation centers, this study aims to collect 300 more biopsies and corresponding blood samples. This study is an extension of the INTERHEART ClinicalTrials.gov Identifier: NCT02670408
- Conditions
- Heart Transplant Rejection
- Being tested
- MMDx diagnostic test, Prospera, HLA antibody
- Keywords
- Donor derived cfDNA, gene expression, heart transplant biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMDx diagnostic testDiagnostic test
Microarray test of gene expression in heart biopsies
ProsperaDiagnostic test
Donor derived cell-free DNA in patient blood
HLA antibodyDiagnostic test
Centralized measurement of HLA antibodies in patient blood
| Study group | Role | What they receive |
|---|---|---|
| Heart transplant protocol and for cause biopsies | The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment. Receives: Diagnostic Test: MMDx diagnostic test; Diagnostic Test: Prospera; Diagnostic Test: HLA antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calibration of Prospera test for T cell-mediated rejection
Set DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx. Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
Measured: 18 months
Calibration of Prospera test for antibody-mediated rejection
Set DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
Measured: 18 months
Calibration of Prospera test for heart injury
Set DD-cfDNA test cut-off values against the probability of acute and chronic heart injury in the biopsy as reported by MMDx.
Measured: 18 month
Report calibrated Prospera test results for rejection
Obtain clinicians feedback
Measured: 6 months
Report calibrated Prospera test results for heart injury
Obtain clinicians feedback
Measured: 6 month
Secondary outcomes (3)
Determine if Prospera blood test can replace heart biopsy test
Obtain clinicians feedback
Measured: 6 month
Determine if Prospera blood test can replace follow up heart biopsy
Determine whether resolution of DD-cfDNA after treatment can monitor response to therapy and avoid follow-up biopsies
Measured: 6 month
Assessment of donor-specific antibody status
Report and compare the DSA status based on centralized and local HLA antibody measurement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jun 2021
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Natera, Inc., One Lambda
- Responsible party
- Sponsor
- Investigators
- Philip F Halloran, MD PhD, Principal investigator, Alberta Transplant Applied Genomics Center, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707872
- Sponsor's protocol ID
- ATAGC06
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only IPD data will be shared within a participating center.
Publications
Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
PubMed 38819301Halloran PF, Madill-Thomsen KS. Donor-derived Cell-free DNA: A Step Forward in the Quest for Transplant Truth. Transplantation. 2025 Jun 1;109(6):910-914. doi: 10.1097/TP.0000000000005332. Epub 2025 Jan 28. No abstract available.
PubMed 39883025Halloran PF, Reeve J, Mackova M, Madill-Thomsen KS, Demko Z, Olymbios M, Campbell P, Melenovsky V, Gong T, Hall S, Stehlik J. Comparing Plasma Donor-derived Cell-free DNA to Gene Expression in Endomyocardial Biopsies in the Trifecta-Heart Study. Transplantation. 2024 Sep 1;108(9):1931-1942. doi: 10.1097/TP.0000000000004986. Epub 2024 Aug 20.
PubMed 38538559Madill-Thomsen KS, Hidalgo LG, Mackova M, Campbell P, Demko Z, Felius J, Gong T, Hall S, Kim DH, Kuczaj A, Lowe D, Maliakkal N, Melenovsky V, Olympios M, Patel S, Prewett A, Przybylowski P, Sayer G, Stehlik J, Tseliou E, Uriel N, Halloran PF. Defining the relationships among four tests for assessing antibody-mediated rejection in heart transplants in a prospective, observational study. J Heart Lung Transplant. 2026 Apr;45(4):659-670. doi: 10.1016/j.healun.2025.10.024. Epub 2025 Nov 13.
PubMed 41241034Madill-Thomsen KS, Hidalgo LG, Mackova M, Demko Z, Prewett A, Campbell P, Felius J, Gong T, Hall S, Kim DH, Kuczaj A, Lowe D, Maliakkal N, Melenovsky V, Olympios M, Patel S, Przybylowski P, Sayer G, Tseliou E, Uriel N, Stehlik J, Halloran PF; Trifecta-Heart Study Group. Comparing DSA-negative and DSA-positive antibody-mediated rejection in heart transplants: Results from the Trifecta-Heart study. J Heart Lung Transplant. 2026 Jul;45(7):1046-1057. doi: 10.1016/j.healun.2026.03.004. Epub 2026 Mar 13.
PubMed 41833593Halloran PF, Madill-Thomsen KS, Biagini DG, Kaur N, Prewett A, Suresh N, Demko ZP, Bhorade S, Olympios M, Gauthier PT, Campbell PT, Gong T, Hall S, Kim DH, Kuczaj A, Przybylowski P, Melenovsky V, Patel SR, Sayer G, Stehlik J, Tseliou E, Uriel N, Mackova M; Trifecta-Heart Investigators. A two-threshold donor-derived cell-free DNA algorithm improves detection of molecular rejection in heart transplantation. J Heart Lung Transplant. 2026 Jun 22:S1053-2498(26)01953-4. doi: 10.1016/j.healun.2026.06.009. Online ahead of print.
PubMed 42331120Halloran PF, Madill-Thomsen KS. The Molecular Microscope Diagnostic System: Assessment of Rejection and Injury in Heart Transplant Biopsies. Transplantation. 2023 Jan 1;107(1):27-44. doi: 10.1097/TP.0000000000004323. Epub 2022 Dec 8.
PubMed 36508644
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
- ClinicalTrials.gov ID
- NCT04707872
- Acronym / sponsor ID
- ATAGC06
- Conditions
- Heart Transplant Rejection
- Keywords
- Donor derived cfDNA, gene expression, heart transplant biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Natera, Inc., One Lambda
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Jan 2021 (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.
Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.
Detailed description
The current standard for assessment of rejection in heart transplants is an endomyocardial biopsy (EMB) interpreted by histology according to ISHLT guidelines. This has considerable error rates, many due to the high disagreement among pathologists in assessing lesions and diagnoses. To address the unmet need for precision and accuracy, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx), which uses microarrays to define the global gene expression features of rejection and injury. Now a new screening test is being introduced: the monitoring of donor-derived cell-free DNA (DD-cfDNA) released in the blood by the heart during rejection. The Natera Inc DD-cfDNA Prospera® test is based on the massively multiplex polymerase chain reaction that targets 13,392 single nucleotide polymorphisms and targeted sequences are quantified by Next Generation Sequencing. The Prospera® test has been done on kidney transplant recipients and detected "active rejection" and differentiated it from borderline rejection and no rejection. However, Prospera® test was not examined (the DD-cfDNA results) in heart transplant recipients. DD-cf-DNA test for heart transplants must now be calibrated against MMDx that is based on global gene expression, the new standard for biopsy interpretation. The present study will calibrate centrally measured (Natera Inc) DD-cfDNA levels obtained at the time of an indication or protocol biopsy against the MMDx measurements of T cell-mediated rejection (TCMR), antibody-mediated rejection (ABMR) and early and late tissue injury. The present study will compare DD-cfDNA and MMDx in 300 prospectively collected biopsies for clinical indications and protocol, and accompanying 600 blood samples, to calibrate the DD-cfDNA (Natera Inc.) levels against the MMDx biopsy diagnoses of TCMR, ABMR (and its stages), and acute (early) and chronic (late) injury, , as well as central assessment of HLA antibody (One Lambda) in 300 blood samples, interpreted centrally as donor specific antibody (DSA) based on the tissue typing results. Trifecta-Heart collected 718 biopsies, 709 cfDNA samples and 706 One Lambda samples so far. Due to a considerable interest from participation centers, this study aims to collect 300 more biopsies and corresponding blood samples. This study is an extension of the INTERHEART ClinicalTrials.gov Identifier: NCT02670408
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart transplant protocol and for cause biopsies | – | Diagnostic Test: MMDx diagnostic test, Diagnostic Test: Prospera, Diagnostic Test: HLA antibodyThe study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications or surveillance (protocol) biopsy.
Key inclusion criteria (2 listed)
- All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study.
- Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent.
Key exclusion criteria (3 listed)
- Patients will be excluded from the study if they decline participation
- Are unable to give informed consent.
- Recipients of multiple organs.
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 |
|---|---|---|
| MMDx diagnostic testMicroarray test of gene expression in heart biopsies | Diagnostic test | Heart transplant protocol and for cause biopsies |
| ProsperaDonor derived cell-free DNA in patient blood | Diagnostic test | Heart transplant protocol and for cause biopsies |
| HLA antibodyCentralized measurement of HLA antibodies in patient blood | Diagnostic test | Heart transplant protocol and for cause biopsies |
Primary outcome
Calibration of Prospera test for T cell-mediated rejection
Time frame: 18 months
Set DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx. Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
Calibration of Prospera test for antibody-mediated rejection
Time frame: 18 months
Set DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
Calibration of Prospera test for heart injury
Time frame: 18 month
Set DD-cfDNA test cut-off values against the probability of acute and chronic heart injury in the biopsy as reported by MMDx.
Report calibrated Prospera test results for rejection
Time frame: 6 months
Obtain clinicians feedback
Report calibrated Prospera test results for heart injury
Time frame: 6 month
Obtain clinicians feedback
3 secondary outcomes
Determine if Prospera blood test can replace heart biopsy test
Time frame: 6 month
Determine if Prospera blood test can replace follow up heart biopsy
Time frame: 6 month
Assessment of donor-specific antibody status
Time frame: 6 months
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 6 Oct 2026.
- Background: PubMed 38819301Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530.
- Background: PubMed 39883025Halloran PF, Madill-Thomsen KS. Donor-derived Cell-free DNA: A Step Forward in the Quest for Transplant Truth. Transplantation. 2025 Jun 1;109(6):910-914. doi: 10.1097/TP.0000000000005332. Epub 2025 Jan 28. No abstract available.
- Results publication: PubMed 38538559Halloran PF, Reeve J, Mackova M, Madill-Thomsen KS, Demko Z, Olymbios M, Campbell P, Melenovsky V, Gong T, Hall S, Stehlik J. Comparing Plasma Donor-derived Cell-free DNA to Gene Expression in Endomyocardial Biopsies in the Trifecta-Heart Study. Transplantation. 2024 Sep 1;108(9):1931-1942. doi: 10.1097/TP.0000000000004986. Epub 2024 Aug 20.
- Results publication: PubMed 41241034Madill-Thomsen KS, Hidalgo LG, Mackova M, Campbell P, Demko Z, Felius J, Gong T, Hall S, Kim DH, Kuczaj A, Lowe D, Maliakkal N, Melenovsky V, Olympios M, Patel S, Prewett A, Przybylowski P, Sayer G, Stehlik J, Tseliou E, Uriel N, Halloran PF. Defining the relationships among four tests for assessing antibody-mediated rejection in heart transplants in a prospective, observational study. J Heart Lung Transplant. 2026 Apr;45(4):659-670. doi: 10.1016/j.healun.2025.10.024. Epub 2025 Nov 13.
- Results publication: PubMed 41833593Madill-Thomsen KS, Hidalgo LG, Mackova M, Demko Z, Prewett A, Campbell P, Felius J, Gong T, Hall S, Kim DH, Kuczaj A, Lowe D, Maliakkal N, Melenovsky V, Olympios M, Patel S, Przybylowski P, Sayer G, Tseliou E, Uriel N, Stehlik J, Halloran PF; Trifecta-Heart Study Group. Comparing DSA-negative and DSA-positive antibody-mediated rejection in heart transplants: Results from the Trifecta-Heart study. J Heart Lung Transplant. 2026 Jul;45(7):1046-1057. doi: 10.1016/j.healun.2026.03.004. Epub 2026 Mar 13.
- Derived from this study: PubMed 42331120Halloran PF, Madill-Thomsen KS, Biagini DG, Kaur N, Prewett A, Suresh N, Demko ZP, Bhorade S, Olympios M, Gauthier PT, Campbell PT, Gong T, Hall S, Kim DH, Kuczaj A, Przybylowski P, Melenovsky V, Patel SR, Sayer G, Stehlik J, Tseliou E, Uriel N, Mackova M; Trifecta-Heart Investigators. A two-threshold donor-derived cell-free DNA algorithm improves detection of molecular rejection in heart transplantation. J Heart Lung Transplant. 2026 Jun 22:S1053-2498(26)01953-4. doi: 10.1016/j.healun.2026.06.009. Online ahead of print.
- Derived from this study: PubMed 36508644Halloran PF, Madill-Thomsen KS. The Molecular Microscope Diagnostic System: Assessment of Rejection and Injury in Heart Transplant Biopsies. Transplantation. 2023 Jan 1;107(1):27-44. doi: 10.1097/TP.0000000000004323. Epub 2022 Dec 8.
- Individual participant dataSharing planned: No. Only IPD data will be shared within a participating center.
Related trials for Heart Transplant Rejection
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
RecruitingPhase 2/3
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
CMV Viremia, Heart Transplant Infection
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
Heart Transplantation
Not yet recruitingObservational study
HEART-BC: Heart Transplant Evaluation Using Advanced Rejection Monitoring Tools - British Columbia
Heart Transplant Recipient
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.
Philip F Halloran, MD PhD principal investigator
Alberta Transplant Applied Genomics Center, University of Alberta
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Rejection, run by University of Alberta at 12 sites in 7 countries.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, Canada, Czechia, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 Konrad Famulski, PhD (1 780 782 9463, konrad@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calibration of Prospera test for T cell-mediated rejection (time frame: 18 months). The study lists 5 primary outcomes in all. 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 NCT04707872, which also lists 7 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 6 Oct 2026.