WithdrawnNot Applicable

Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation

Stopped: Sponsor made decision to pause study while it was still in development phase. The FDA and IRB approval process had not been completed. No sites were activated. No subjects had been recruited for this study.

0Started 2023-01

Plain-language summary

The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first post-transplant year.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female, age 18 years or older at the time of signing informed consent.
. On the heart transplant waiting list and expected to receive a heart transplant.
. Able to read, understand and provide written informed consent.
. Able and willing to comply with the study visit schedule, study procedures and study requirements.

Exclusion criteria

. Heart transplantation has been performed.
. Concurrent multiple solid organ or tissue transplant
. Prior history of any organ or cellular transplantation.
. Planned use of other commercially available or investigational cfDNA or gene expression profile assays.
. Pregnant.
. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demonstrate the use of Prospera for post-transplant surveillance is non-inferior to the current standard of care, EMB surveillance, with respect to the primary composite endpoint.

Timeframe: 12 months

Trial details

NCT IDNCT05081739

SponsorNatera, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01

View on ClinicalTrials.gov More Heart Transplant Failure and Rejection trials