Surveillance HeartCare® Outcomes Registry
SHORE
1 other identifier
observational
2,743
1 country
67
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Longer than P75 for all trials
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
December 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
April 22, 2026
April 1, 2026
7.8 years
September 28, 2018
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Interventions
Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody
Eligibility Criteria
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.
You may qualify if:
- Patients who are 15 years of age or older at the time of blood draw.
- Received a heart transplant (primary or repeat)
- Patients who have HeartCare initiated within 3 months post-transplant
You may not qualify if:
- \. Patients who are pregnant at the time of blood draw.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CareDxlead
Study Sites (67)
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
Baptist Health Arkansas
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
Related Publications (8)
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.
PMID: 28624139BACKGROUNDCrespo-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.
PMID: 26746629BACKGROUNDDe 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.
PMID: 24944192BACKGROUNDDeng 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.
PMID: 16433769BACKGROUNDGrskovic 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.
PMID: 27727019BACKGROUNDKobashigawa 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.
PMID: 25697852BACKGROUNDPham 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.
PMID: 20413602BACKGROUNDKim 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.
PMID: 41123513DERIVED
Biospecimen
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiran Khush, MD
Stanford University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 4, 2018
Study Start
December 28, 2018
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04