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NCT04707872 · ClinicalTrials.gov registry record
Trifecta-Heart cfDNA-MMDx Study
A clinical trial of Heart Transplant Rejection, sponsored by University of Alberta.
- Recruiting
- Registry status
- 300
- Enrollment target
- 12
- Study locations
NCT04707872: Recruiting study of Heart Transplant Rejection, sponsored by University of Alberta.
NCT04707872 is a study of Heart Transplant Rejection that is actively recruiting participants, run by University of Alberta. The registered enrollment target is 300 participants, below the 681-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (56% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04707872, a study of Heart Transplant Rejection, is actively recruiting participants, sponsored by University of Alberta.
- RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 12
- Study locations
Study 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.
Primary Outcome
Set DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx. Calibration of DD-cfDNA test cut-off values against the probability of T cell-mediated rejection in the biopsy as reported by MMDx.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST MMDx diagnostic test
- DIAGNOSTIC_TEST Prospera
- DIAGNOSTIC_TEST HLA antibody
Study Locations (12)
Other
- Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute - Darlinghurst
- Institute for Clinical and Experimental Medicine - IKEM Videnska 1958/9 - Prague
- Heart Failure and Heart Transplant Unit, University of Bologna - Bologna
- Silesian Center for Heart Diseases (Ś!ąskie Centrum Chorób Serca w Zabrzu - Zabrze
- Advanced Heart Failure Transplant Unit - A Coruña
Arkansas
- Baptist Health Institute for Research and Innovation - Little Rock
Florida
- Tampa General Hospital, 409 Bayshore Blvd. - Tampa
New Jersey
- Columbia University Medical Center, Columbia Interventional Cardiovascular Care - West New York
New York
- Montefiore Medical Center, 3319 Rochambeau Avenue, 2nd FL - The Bronx
Texas
- Annette C. and Harold C. Simmons Transplant Institute, BaylorScott&White Research Institute - Dallas
Utah
- Cardiovascular Medicine, University of Utah Health - Salt Lake City
Alberta
- Division of Cardiology, University of Alberta - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2027-07 |
What NCT04707872 shows while recruiting
NCT04707872 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 681-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Heart Transplant Rejection appearing as the primary indexed condition, and to 3 interventions - of which MMDx diagnostic test is the first listed.
NCT04707872 lists 12 locations in 8 states (Other, Arkansas, Florida).
Frequently Asked Questions
What is clinical trial NCT04707872 about?
NCT04707872 is a clinical study titled "Trifecta-Heart cfDNA-MMDx Study". 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.
What is the current status of trial NCT04707872?
This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2021-06-01. Estimated completion is 2027-07.
What conditions does trial NCT04707872 study?
This clinical trial studies the following conditions: Heart Transplant Rejection.
What interventions are being tested in trial NCT04707872?
The interventions under investigation include: MMDx diagnostic test (DIAGNOSTIC_TEST), Prospera (DIAGNOSTIC_TEST), HLA antibody (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04707872?
This trial is sponsored by University of Alberta, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04707872 being conducted?
This trial has 12 study locations across Arkansas, Florida, New Jersey, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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