Trifecta-Heart cfDNA-MMDx Study
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ClinicalTrials.gov Identifier: NCT04707872 |
Recruitment Status :
Recruiting
First Posted : January 13, 2021
Last Update Posted : May 3, 2024
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Condition or disease | Intervention/treatment |
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Heart Transplant Rejection | Diagnostic Test: MMDx diagnostic test Diagnostic Test: Prospera Diagnostic Test: HLA antibody |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test |
Actual Study Start Date : | June 1, 2021 |
Estimated Primary Completion Date : | December 2024 |
Estimated Study Completion Date : | July 2025 |
Group/Cohort | Intervention/treatment |
---|---|
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.
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Diagnostic Test: MMDx diagnostic test
Microarray test of gene expression in heart biopsies Diagnostic Test: Prospera Donor derived cell-free DNA in patient blood Diagnostic Test: HLA antibody Centralized measurement of HLA antibodies in patient blood |
- 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
- Determine if Prospera blood test can replace heart biopsy test [ Time Frame: 6 month ]Obtain clinicians feedback
- Determine if Prospera blood test can replace follow up heart biopsy [ Time Frame: 6 month ]Determine whether resolution of DD-cfDNA after treatment can monitor response to therapy and avoid follow-up biopsies
- Assessment of donor-specific antibody status [ Time Frame: 6 months ]Report and compare the DSA status based on centralized and local HLA antibody measurement.
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients will be excluded from the study if they decline participation
- Are unable to give informed consent.
- Recipients of multiple organs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04707872
Contact: Konrad Famulski, PhD | 1 780 782 9463 | konrad@ualberta.ca | |
Contact: Robert Polakowski, PhD | 1 780 492 5091 | polakows@ualberta.ca |
United States, Arkansas | |
Baptist Health Institute for Research and Innovation | Recruiting |
Little Rock, Arkansas, United States, 72205 | |
Contact: Victoria McIntosh Marren victoria.mcintosh@baptist-health.org | |
Principal Investigator: Patrick Campbell, MD | |
United States, California | |
UCLA Medical Centre | Not yet recruiting |
Los Angeles, California, United States, 90024 | |
Contact: Eugene DePasquale, MD EDepasquale@mednet.ucla.edu | |
Principal Investigator: Martin Cadeiras, MD | |
Sub-Investigator: Mario Deng, MD | |
Cedars-Sinai Heart Institute | Not yet recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Brandy Starks, MBA 310-248-7141 jon.kobashigawa@cshs.org | |
Contact: Kobashigawa, MD jon.kobashigawa@cshs.org | |
Principal Investigator: Jon Kobashigawa | |
United States, New Jersey | |
Columbia University Medical Center, Columbia Interventional Cardiovascular Care | Recruiting |
W. New York, New Jersey, United States, 10032 | |
Contact: Maria Alejandra Muñoz Cifuentes mam2649@cumc.columbia.edu | |
Principal Investigator: Gabriel Sayer, MD | |
United States, New York | |
Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL | Recruiting |
Bronx, New York, United States, 10467 | |
Contact: Renae Robinson rerobins@montefiore.org | |
Contact: Brandon Johnson brajohnson@montefiore.org | |
Principal Investigator: Snehal Patel | |
United States, Texas | |
Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute | Recruiting |
Dallas, Texas, United States, 75246 | |
Contact: Aayla K Jamil, MBBS Aayla.Jamil@BSWHealth.org | |
Principal Investigator: Shelley Hall, MD | |
United States, Utah | |
Cardiovascular Medicine, University of Utah Health | Recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Jennifer Hong Jennifer.Hong@hsc.utah.edu | |
Principal Investigator: Josef Stehlik, MD, PhD | |
Australia | |
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute | Not yet recruiting |
Darlinghurst, Australia, NSW 2010 | |
Contact: Carmen Herrera, MD peter.macdonal@svha.org.au | |
Principal Investigator: Peter MacDonald, MD | |
Austria | |
Department of Cardiac Surgery, Medical University of Vienna | Not yet recruiting |
Vienna, Austria, A-1090 | |
Contact: Arezu Aliabadi, MD arezu.aliabadi@meduniwien.ac.at | |
Principal Investigator: Andreas Zuckerman, MD | |
Sub-Investigator: Johannes Gokler, MD | |
Canada, Alberta | |
Division of Cardiology, University of Alberta | Recruiting |
Edmonton, Alberta, Canada, T6G 2R7 | |
Contact: Daniel Kim, MD dk@ualberta.ca | |
Principal Investigator: Daniel Kim, MD | |
Czechia | |
Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9 | Recruiting |
Prague, Czechia, 140 21 | |
Contact: Tereza Novakowa novt@ikem.cz | |
Principal Investigator: Vojtech Melenovsky, MD PhD | |
Italy | |
Heart Failure and Heart Transplant Unit, University of Bologna | Not yet recruiting |
Bologna, Italy, 40138 | |
Contact: Laura Borgese laura.borgese@gmail.com | |
Principal Investigator: Luciano Potena, MD | |
Poland | |
Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu | Recruiting |
Zabrze, Poland, 41-800 | |
Contact: Piotr Przybylowski, Professor +48 502 264 910 P.Przybylowski@sccs.pl | |
Principal Investigator: Piotr Przybylowski, Professor | |
Spain | |
Advanced Heart Failure Transplant Unit | Recruiting |
La Coruna, Spain | |
Contact: Zulaika Grille Cancela Zulaika.grille.cancela@sergas.es | |
Principal Investigator: Maria G Crespo-Leiro, MD |
Principal Investigator: | Philip F Halloran, MD PhD | Alberta Transplant Applied Genomics Center, University of Alberta |
Responsible Party: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT04707872 |
Other Study ID Numbers: |
ATAGC06 |
First Posted: | January 13, 2021 Key Record Dates |
Last Update Posted: | May 3, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Only IPD data will be shared within a participating center. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Donor derived cfDNA gene expression heart transplant biopsy |
Antibodies Immunologic Factors Physiological Effects of Drugs |