Surveillance HeartCare® Outcomes Registry

NCT03695601 · tracked via the Priya Life Science USA tracker

Sponsor

CareDx

Phase

Observational

Started

2018-12-28

Last updated

2026-09-03

Condition(s) studied

Heart Transplant Rejection

Investigational drug(s) / intervention(s)

Standard of Care

Standard of Care: Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody

Study 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.

Eligibility

Sex

ALL

Min age

15 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients who are 15 years of age or older at the time of blood draw. 2. Received a heart transplant (primary or repeat) 3. Patients who have HeartCare initiated within 3 months post-transplant Exclusion Criteria: 1\. Patients who are pregnant at the time of blood draw.

Primary outcome measure(s)

Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. — Dec-2026
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.

Trial sites (67)

Facility	City	Region
Mayo Clinic Arizona	Phoenix	Arizona
Baptist Health Arkansas	Little Rock	Arkansas
University of California San Diego	La Jolla	California
Cedars-Sinai Medical Center	Los Angeles	California
University of California, Los Angeles	Los Angeles	California
University of Southern California	Los Angeles	California
California Pacific Medical Center	San Francisco	California
University of California San Fransisco Medical Center	San Francisco	California
Stanford University	Stanford	California
Yale New Haven	New Haven	Connecticut
Medstar Washington Hospital Center	Washington D.C.	District of Columbia
Memorial Healthcare System	Hollywood	Florida
Mayo Clinic- Florida	Jacksonville	Florida
University of Miami	Miami	Florida
Advent Health	Orlando	Florida
Tampa General Hospital	Tampa	Florida
Piedmont Heart Institute	Atlanta	Georgia
Northwestern University	Chicago	Illinois
University of Chicago Medicine	Chicago	Illinois
Loyola University Medical Center	Maywood	Illinois
Advocate Christ Medical Center	Oak Lawn	Illinois
Indiana University School of Medicine	Indianapolis	Indiana
Ascension St. Vincent Hospital and Health Care Center	Indianapolis	Indiana
The University of Kansas Medical Center	Kansas City	Kansas
Ochsner Clinic Foundation	New Orleans	Louisiana
Tufts Medical Center	Boston	Massachusetts
Massachusetts General Hospital	Boston	Massachusetts
Henry Ford Health System	Detroit	Michigan
Spectrum Health	Grand Rapids	Michigan
Mayo Clinic Rochester	Rochester	Minnesota
St. Luke's Hospital of Kansas City	Kansas City	Missouri
Barnes Jewish Hospital, Washington University	St Louis	Missouri
University of Nebraska Medical Center	Omaha	Nebraska
Northwell Health/ North Shore University Hospital	Manhassett	New York
NYU Langone Health	New York	New York
Icahn School of Medicine at Mount Sinai	New York	New York
Columbia University Irving Medical Center	New York	New York
University of Rochester Medical Center	Rochester	New York
Montefiore Medical Center	The Bronx	New York
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

+ 27 more sites — see the full list on the official registry below.

More CareDx trials in the USA

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Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD) Starting soon

AlloSure Lung Assessment and Metagenomics Outcomes Study Active, not recruiting

Molecular Assessment and Profiling of Liver Transplant Recipients Active, not recruiting

Other trials for the same condition

Prospera Test Evaluation in Cardiac Transplant (ProTECT) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03695601 on ClinicalTrials.gov ↗ ← All trials in the USA