CompletedNot Applicable

HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection

United States, Canada196 participantsStarted 2018-08-09

Plain-language summary

Heart transplantation is a life saving therapy for people with end stage heart failure. Acute rejection, a process where the immune system recognizes the transplanted heart as foreign and mounts a response against it, remains a clinical problem despite improvements in immunosuppressive drugs. Acute rejection occurs in 20-30% of patients within the first 3 months post-transplant, and is currently detected by highly invasive heart tissue biopsies that happen 12-15 times in the first year post-transplant. Replacing the biopsy with a simple blood test is of utmost value to patients and will reduce healthcare costs. The goal of our project is to develop a new blood test to monitor heart transplant rejection. Advances in biotechnology have enabled simultaneous measurement of many molecules (e.g., proteins, nucleic acids) in blood, driving the development of new diagnostics. Our team is a leader in using computational tools to combine information from numerous biological molecules and clinical data to generate "biomarker panels" that are more powerful than existing diagnostic tests. Our sophisticated analytic methods has recently derived HEARTBiT, a promising test of acute rejection comprising 9 RNA biomarkers, from the measurement of 30,000 blood molecules in 150 Canadian heart transplant patients. Our objective is to study a custom-built HEARTBiT test in a setting and on a technology that enable clinical adoption. We will evaluate the new test on 400 new patients from 5 North American transplant centres. We will also track patients' HEARTBiT scores over time to help predict future rejection, and explore use of proteins and micoRNAs to improve HEARTBiT. Our work will provide the basis for a future clinical trial. The significance of this work rests in that it will provide a tool to identify acute cardiac rejection in a fast, accurate, cost-effective and minimally invasive manner, allowing for facile long-term monitoring and therapy tailoring for heart transplant patients.

Who can participate

Age range

19 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.

Heart Transplant Subjects: Inclusion Criteria * recipients who are ≥ 19 years of age * willing and able to provide informed consent Exclusion Criteria * recipients under 19 years of age * recipients who have received multiple, different solid organ transplants (i.e. a heart and a kidney) * recipients who are HIV positive * recipients of organs from donors who test positive for HIV Normal Subjects: Inclusion Criteria * all individuals who are ≥ 19 years of age * willing and able to provide informed consent

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.

1Since this trial has already completed, has my transplant team seen or reviewed the HEARTBiT biomarker panel findings, and could those results change how they monitor me for acute rejection after my transplant?
2Right now, what method does my care team use to detect acute cardiac rejection — is it still primarily endomyocardial biopsy — and could a blood-based test like the one studied in HEARTBiT ever become part of my monitoring plan?
3This trial measured a panel of biomarkers on a specific lab platform called NanoString — is this type of blood test currently available in clinical practice, or is it still considered experimental and not yet an option outside of research?
4Since the trial focused on distinguishing acute rejection from non-rejection or mild rejection samples, does this mean a test like HEARTBiT would be most useful in a specific situation — like when I'm already showing symptoms — rather than as routine surveillance?
5Are there other completed or ongoing studies building on this kind of multi-marker blood test approach that my doctor thinks are worth watching, especially if I want to reduce my exposure to invasive biopsy procedures over time?

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

Comparison of the HEARTBiT Biomarker Panel Score (BPS) between acute rejection and non-rejection/mild-rejection samples on the NanoString platform.

Timeframe: Within 5 years

Trial details

NCT IDNCT03575910

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-30

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