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New registry monitors heart transplant patients for better rejection detection

NCT ID NCT03695601

Knowledge-focused Sponsor: CareDx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study follows over 2,700 heart transplant recipients to see how well HeartCare testing services work in routine care. Researchers will track whether patients develop certain antibodies that may signal rejection. The goal is to understand if regular monitoring helps catch problems early.

Why investors are watching

CareDx is running an observational registry of 2,743 heart transplant recipients who use its HeartCare testing services. For a small company, this registry can show whether its surveillance tests help doctors manage patients in real-world care, which supports broader adoption of its products.

If it works: A positive result could strengthen the case that HeartCare tests provide clinical value, which may encourage more transplant centers to use them and support the company's revenue growth.

If it fails: Observational registries often produce mixed or inconclusive results, and a weak outcome could slow adoption of the tests. The trial may also face delays or incomplete data, which would leave the company without a clear readout.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,743 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2018

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart transplant rejection

Contacts and locations

Locations

  • Advent Health

    Orlando, Florida, 32804, United States

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Seton

    Austin, Texas, 78705, United States

  • Ascension St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260, United States

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53233, United States

  • Baptist Health Arkansas

    Little Rock, Arkansas, 72211, United States

  • Barnes Jewish Hospital, Washington University

    St Louis, Missouri, 63110, United States

  • Baylor Research Institute

    Dallas, Texas, 75246, United States

  • Baylor St. Luke's Medical Center

    Houston, Texas, 77030, United States

  • California Pacific Medical Center

    San Francisco, California, 94115, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202, United States

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042, United States

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112, United States

  • Intermountain Heart Institute

    Murray, Utah, 84107, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic- Florida

    Jacksonville, Florida, 32224, United States

  • Medical City Dallas

    Dallas, Texas, 75230, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Methodist Healthcare Systems of San Antonio

    San Antonio, Texas, 78229, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwell Health/ North Shore University Hospital

    Manhassett, New York, 11030, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, 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

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309, United States

  • Saint Thomas Health

    Nashville, Tennessee, 37205, United States

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507, United States

  • Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UTHealth/ Memorial Hermann Hospital

    Houston, Texas, 77030, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of California San Fransisco Medical Center

    San Francisco, California, 94143, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Southern California

    Los Angeles, California, 94003, United States

  • University of Washington

    Seattle, Washington, 98115, United States

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53726, United States

  • Wake Forest Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Yale New Haven

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.