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Clinical Trials in the USA / NCT03695601
Active, not recruiting Observational

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
No
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)

FacilityCityRegionStatus
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

Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD) Enrolling by invitation
Molecular Assessment and Profiling of Liver Transplant Recipients Active, not recruiting
AlloSure Lung Assessment and Metagenomics Outcomes Study 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