RecruitingNot Applicable

Trifecta-Heart cfDNA-MMDx Study

United States, Australia, Canada300 participantsStarted 2021-06-01

Plain-language summary

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

Who can participate

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: * All heart transplant recipients undergoing a biopsy for clinical indications and protocol biopsies, as determined by their physician or surgeon, will be eligible to enroll in the study. * Patients are enrolled based on standard of care biopsies, including surveillance biopsies in high-risk patients, with informed consent. Exclusion Criteria: * Patients will be excluded from the study if they decline participation * Are unable to give informed consent. * Recipients of multiple organs.

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

Calibration of Prospera test for T cell-mediated rejection

Timeframe: 18 months

Calibration of Prospera test for antibody-mediated rejection

Timeframe: 18 months

Calibration of Prospera test for heart injury

Timeframe: 18 month

Report calibrated Prospera test results for rejection

Timeframe: 6 months

Report calibrated Prospera test results for heart injury

Timeframe: 6 month

Trial details

NCT IDNCT04707872

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12

Contact for this trial

Konrad Famulski, PhD

1 780 782 9463 konrad@ualberta.ca

View on ClinicalTrials.gov More Heart Transplant Rejection trials

Who can participate

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.

What they're measuring

Calibration of Prospera test for T cell-mediated rejection

Timeframe: 18 months

Calibration of Prospera test for antibody-mediated rejection

Timeframe: 18 months

Calibration of Prospera test for heart injury

Timeframe: 18 month

Report calibrated Prospera test results for rejection

Timeframe: 6 months

Report calibrated Prospera test results for heart injury

Timeframe: 6 month