Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04707872
Registration number
NCT04707872
Ethics application status
Date submitted
11/01/2021
Date registered
13/01/2021
Titles & IDs
Public title
Trifecta-Heart cfDNA-MMDx Study
Query!
Scientific title
Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
Query!
Secondary ID [1]
0
0
ATAGC06
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Heart Transplant Rejection
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Diagnosis / Prognosis - MMDx diagnostic test
Diagnosis / Prognosis - Prospera
Diagnosis / Prognosis - HLA antibody
Heart transplant protocol and for cause biopsies - The study population includes patients with a functioning heart transplant undergoing a biopsy for clinical indications as standard of care, or protocol biopsies of heart in high-risk patients, or follow-up after treatment.
Diagnosis / Prognosis: MMDx diagnostic test
Microarray test of gene expression in heart biopsies
Diagnosis / Prognosis: Prospera
Donor derived cell-free DNA in patient blood
Diagnosis / Prognosis: HLA antibody
Centralized measurement of HLA antibodies in patient blood
Query!
Intervention code [1]
0
0
Diagnosis / Prognosis
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Calibration of Prospera test for T cell-mediated rejection
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
18 months
Query!
Primary outcome [2]
0
0
Calibration of Prospera test for antibody-mediated rejection
Query!
Assessment method [2]
0
0
Set DD-cfDNA test cut-off values against the probability of antibody-mediated rejection in the biopsy as reported by MMDx.
Query!
Timepoint [2]
0
0
18 months
Query!
Primary outcome [3]
0
0
Calibration of Prospera test for heart injury
Query!
Assessment method [3]
0
0
Set DD-cfDNA test cut-off values against the probability of acute and chronic heart injury in the biopsy as reported by MMDx.
Query!
Timepoint [3]
0
0
18 month
Query!
Primary outcome [4]
0
0
Report calibrated Prospera test results for rejection
Query!
Assessment method [4]
0
0
Obtain clinicians feedback
Query!
Timepoint [4]
0
0
6 months
Query!
Primary outcome [5]
0
0
Report calibrated Prospera test results for heart injury
Query!
Assessment method [5]
0
0
Obtain clinicians feedback
Query!
Timepoint [5]
0
0
6 month
Query!
Secondary outcome [1]
0
0
Determine if Prospera blood test can replace heart biopsy test
Query!
Assessment method [1]
0
0
Obtain clinicians feedback
Query!
Timepoint [1]
0
0
6 month
Query!
Secondary outcome [2]
0
0
Determine if Prospera blood test can replace follow up heart biopsy
Query!
Assessment method [2]
0
0
Determine whether resolution of DD-cfDNA after treatment can monitor response to therapy and avoid follow-up biopsies
Query!
Timepoint [2]
0
0
6 month
Query!
Secondary outcome [3]
0
0
Assessment of donor-specific antibody status
Query!
Assessment method [3]
0
0
Report and compare the DSA status based on centralized and local HLA antibody measurement.
Query!
Timepoint [3]
0
0
6 months
Query!
Eligibility
Key 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.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients will be excluded from the study if they decline participation
* Are unable to give informed consent.
* Recipients of multiple organs.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2027
Query!
Actual
Query!
Sample size
Target
300
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute - Darlinghurst
Query!
Recruitment postcode(s) [1]
0
0
NSW 2010 - Darlinghurst
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
New Jersey
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New York
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Utah
Query!
Country [7]
0
0
Austria
Query!
State/province [7]
0
0
Vienna
Query!
Country [8]
0
0
Canada
Query!
State/province [8]
0
0
Alberta
Query!
Country [9]
0
0
Czechia
Query!
State/province [9]
0
0
Prague
Query!
Country [10]
0
0
Italy
Query!
State/province [10]
0
0
Bologna
Query!
Country [11]
0
0
Poland
Query!
State/province [11]
0
0
Zabrze
Query!
Country [12]
0
0
Spain
Query!
State/province [12]
0
0
La Coruna
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Alberta
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Natera, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
One Lambda
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04707872
Query!
Trial related presentations / publications
Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530. Halloran PF, Reeve J, Mackova M, Madill-Thomsen KS, Demko Z, Olymbios M, Campbell P, Melenovsky V, Gong T, Hall S, Stehlik J. Comparing Plasma Donor-derived Cell-free DNA to Gene Expression in Endomyocardial Biopsies in the Trifecta-Heart Study. Transplantation. 2024 Sep 1;108(9):1931-1942. doi: 10.1097/TP.0000000000004986. Epub 2024 Aug 20.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Philip F Halloran, MD PhD
Query!
Address
0
0
Alberta Transplant Applied Genomics Center, University of Alberta
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Konrad Famulski, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1 780 782 9463
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Only IPD data will be shared within a participating center.
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Halloran PF, Reeve J, Mackova M, Madill-Thomsen KS...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT04707872