NCT03575910: HEARTBiT

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

Active, enrolled Last updated 10 April 2025

What this trial tests

trial in Heart Transplant Failure and Rejection in 196 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 August 2018

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	University of British Columbia
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	196
Start date	9 August 2018
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	4 locations across Canada, United States

Conditions studied

• Heart Transplant Failure and Rejection — all drugs for Heart Transplant Failure and Rejection →
• Heart Failure — all drugs for Heart Failure →
• Heart Diseases — all drugs for Heart Diseases →
• Heart Failure，Congestive — all drugs for Heart Failure，Congestive →

Sponsor

University of British Columbia

Who can join

19 and older, any sex, with Heart Transplant Failure and Rejection or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Muscle Regeneration and RNA: New Perspectives for Ancient Molecules.
   Buonaiuto G, Desideri F, Taliani V, Ballarino M. · · 2021 · cited 9× · PMID 34685492 · DOI 10.3390/cells10102512
2. Association between tacrolimus blood levels and biopsy-proven acute cellular rejection in adult heart transplant recipients.
   Yang C, Shannon CP, Assadian S, Lapp L, et al · · 2025 · PMID 40979523 · DOI 10.1016/j.jhlto.2025.100373