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NCT03575910 · ClinicalTrials.gov registry record
HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection
A clinical trial of Heart Failure and Heart Diseases, sponsored by University of British Columbia.
- Active
- Registry status
- 196
- Enrollment target
- 4
- Study locations
NCT03575910 is a study of Heart Failure and Heart Diseases that is active but no longer recruiting, run by University of British Columbia. The registered enrollment target is 196 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT03575910, a study of Heart Failure and Heart Diseases, is active but no longer recruiting, sponsored by University of British Columbia.
- ACTIVE NOT RECRUITING
- Registry status
- 196 participants
- Enrollment target
- 4
- Study locations
Study 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.
Conditions Studied
Study Locations (4)
Ontario
- Ottawa Heart Institute - Ottawa
- Toronto General Hospital UHN - Toronto
Nebraska
- University of Nebraska Medical Center - Omaha
British Columbia
- St. Paul's Hospital - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2025-12-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03575910
The ClinicalTrials.gov registry entry for NCT03575910 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (90% lower). The listed sponsor is University of British Columbia, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Heart Failure appearing as the primary indexed condition, and to 0 interventions.
NCT03575910 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Ontario, Nebraska, British Columbia.
Frequently Asked Questions
What is clinical trial NCT03575910 about?
NCT03575910 is a clinical study titled "HEARTBiT: Multi-Marker Blood Test for Acute Cardiac Transplant Rejection". 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 ...
What is the current status of trial NCT03575910?
This trial is currently active not recruiting. The enrollment target is 196 participants. The study started on 2018-08-09. Estimated completion is 2025-12-30.
What conditions does trial NCT03575910 study?
This clinical trial studies the following conditions: Heart Failure, Heart Diseases, Heart Transplant Failure and Rejection, Heart Failure，Congestive, Transplant; Failure, Heart.
Who is sponsoring clinical trial NCT03575910?
This trial is sponsored by University of British Columbia, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03575910 being conducted?
This trial has 4 study locations across Nebraska, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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