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Blood test could replace painful heart biopsies for transplant patients

NCT ID NCT06414603

Disease control Sponsor: Natera, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares a simple blood test (Prospera) to the standard heart biopsy for monitoring rejection in heart transplant patients. About 250 adults waiting for or who have received a heart transplant will be randomly assigned to one of two monitoring methods. The goal is to see if the blood test is as effective as the biopsy at detecting rejection and preventing complications.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

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

Started

Jun 2024

Expected to finish

Feb 2027

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.

Ages

18 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. Age 18 years or older at the time of signing informed consent. 2. Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant. 3. Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient. 4. Able and willing to comply with the study visit schedule, study procedures and study requirements. Exclusion Criteria: 1. Concurrent multiple solid organ or tissue transplants. 2. Prior history of any organ or cellular transplantation. 3. Planned use of other commercially available or investigational cfDNA or gene expression profile assays for rejection surveillance. 4. Pregnant. 5. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study.

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Conditions

The condition(s) this trial relates to.

Rejection, Psychology transplant rejection

As listed by the trial registrant

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

Heart transplant failure and rejection

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Baylor Scott White - Temple

    Temple, Texas, 76508, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Inova Schar Heart and Vascular Institute

    Falls Church, Virginia, 22042, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of California, San Diego

    San Diego, California, 92103, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Texas, Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

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