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This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
HeartCare is a service which includes AlloMap® and AlloSure-Heart® to provide information to help clinicians to more comprehensively monitor heart transplant recipients for allograft rejection. An approach to surveillance using HeartCare provides information from two complementary measures; AlloMap is a gene-expression profile based measure of host immune activity and risk of acute rejection. AlloSure-Heart monitors graft injury. AlloMap is the first FDA cleared test and is the only non-invasive, blood test method recommended in the International Society for Heart and Lung Transplantation (ISHLT) guidelines for surveillance of heart transplant recipients for rejection. AlloSure-Heart measures donor-derived cell-free DNA (dd-cfDNA) to help discriminate acute cellular rejection and antibody-mediated rejection from no rejection. Patients who receive HeartCare, as part of their post-transplant management, will give informed consent for information on their outcomes and other relevant clinical information, found in their medical records, to be entered into a SHORE database for purposes of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartCare | Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® ) |
| |
| Control | A historical control group will be matched to the estimated 1150 HeartCare group patients who complete at least two years of HeartCare surveillance use and inclusive of year 3 post-transplant clinical follow-up for outcome. The criteria for the matched controls will be based on allograft donor type, age, gender, ethnicity/race, and other clinical factors. Propensity scores will be used to perform the matching. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. | The primary endpoint of the study is the proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. The overall incidence of de-novo DSA is between 10-20% in the first year and 10-15% each year subsequently. | Dec-2026 |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients who are pregnant at the time of blood draw.
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All eligible heart transplant recipients who meet the inclusion/exclusion criteria will be a part of this observational study.
The control cohort will include the historical patients cared for without the use of HeartCare at the participating centers.
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| Name | Affiliation | Role |
|---|---|---|
| Kiran Khush, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Baptist Health Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28624139 | Background | Agbor-Enoh S, Tunc I, De Vlaminck I, Fideli U, Davis A, Cuttin K, Bhatti K, Marishta A, Solomon MA, Jackson A, Graninger G, Harper B, Luikart H, Wylie J, Wang X, Berry G, Marboe C, Khush K, Zhu J, Valantine H. Applying rigor and reproducibility standards to assay donor-derived cell-free DNA as a non-invasive method for detection of acute rejection and graft injury after heart transplantation. J Heart Lung Transplant. 2017 Sep;36(9):1004-1012. doi: 10.1016/j.healun.2017.05.026. Epub 2017 May 20. | |
| 26746629 |
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For AlloMap, RNA isolated from peripheral blood mononuclear cells (PBMC) For AlloSure-Heart, plasma from venous blood will be collected and cell-free DNA will be extracted from the plasma for analysis of donor-derived cell-free DNA
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| University of California San Diego | La Jolla | California | 92037 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| University of Southern California | Los Angeles | California | 94003 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of California San Fransisco Medical Center | San Francisco | California | 94143 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Yale New Haven | New Haven | Connecticut | 06519 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Mayo Clinic- Florida | Jacksonville | Florida | 32224 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Advent Health | Orlando | Florida | 32804 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Ascension St. Vincent Hospital and Health Care Center | Indianapolis | Indiana | 46260 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Barnes Jewish Hospital, Washington University | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Northwell Health/ North Shore University Hospital | Manhassett | New York | 11030 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny-Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| Saint Thomas Health | Nashville | Tennessee | 37205 | United States |
| Ascension Seton | Austin | Texas | 78705 | United States |
| Medical City Dallas | Dallas | Texas | 75230 | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| UTHealth/ Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Methodist Healthcare Systems of San Antonio | San Antonio | Texas | 78229 | United States |
| Intermountain Heart Institute | Murray | Utah | 84107 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| University of Washington | Seattle | Washington | 98115 | United States |
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53726 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Aurora Research Institute | Milwaukee | Wisconsin | 53233 | United States |
| Background |
| Crespo-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. |
| 24944192 | Background | De Vlaminck I, Valantine HA, Snyder TM, Strehl C, Cohen G, Luikart H, Neff NF, Okamoto J, Bernstein D, Weisshaar D, Quake SR, Khush KK. Circulating cell-free DNA enables noninvasive diagnosis of heart transplant rejection. Sci Transl Med. 2014 Jun 18;6(241):241ra77. doi: 10.1126/scitranslmed.3007803. |
| 16433769 | Background | Deng 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. |
| 27727019 | Background | Grskovic M, Hiller DJ, Eubank LA, Sninsky JJ, Christopherson C, Collins JP, Thompson K, Song M, Wang YS, Ross D, Nelles MJ, Yee JP, Wilber JC, Crespo-Leiro MG, Scott SL, Woodward RN. Validation of a Clinical-Grade Assay to Measure Donor-Derived Cell-Free DNA in Solid Organ Transplant Recipients. J Mol Diagn. 2016 Nov;18(6):890-902. doi: 10.1016/j.jmoldx.2016.07.003. Epub 2016 Oct 7. |
| 25697852 | Background | Kobashigawa J, Patel J, Azarbal B, Kittleson M, Chang D, Czer L, Daun T, Luu M, Trento A, Cheng R, Esmailian F. Randomized pilot trial of gene expression profiling versus heart biopsy in the first year after heart transplant: early invasive monitoring attenuation through gene expression trial. Circ Heart Fail. 2015 May;8(3):557-64. doi: 10.1161/CIRCHEARTFAILURE.114.001658. Epub 2015 Feb 19. |
| 20413602 | Background | Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med. 2010 May 20;362(20):1890-900. doi: 10.1056/NEJMoa0912965. Epub 2010 Apr 22. |
| 41123513 | Derived | Kim PJ, Alam AH, Teuteberg JJ, Khush KK, Pinney SP, Cheng RK, Yehya A, Kobulnik J, Pinney KM, Oreschak KA, Ensor CR, Fan S, Urey MA, Shah P, Hall SA. Donor-Derived Cell-Free DNA in Antibody-Mediated Rejection: An Analysis of the Surveillance HeartCare Outcomes Registry. JACC Heart Fail. 2026 Jan;14(1):102716. doi: 10.1016/j.jchf.2025.102716. Epub 2025 Oct 22. |
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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