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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
Date last updated
24/10/2024

Titles & IDs
Public title
Trifecta-Heart cfDNA-MMDx Study
Scientific title
Trifecta-Heart cfDNA-MMDX Study: Comparing the DD-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test
Secondary ID [1] 0 0
ATAGC06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Transplant Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Calibration of Prospera test for T cell-mediated rejection
Timepoint [1] 0 0
18 months
Primary outcome [2] 0 0
Calibration of Prospera test for antibody-mediated rejection
Timepoint [2] 0 0
18 months
Primary outcome [3] 0 0
Calibration of Prospera test for heart injury
Timepoint [3] 0 0
18 month
Primary outcome [4] 0 0
Report calibrated Prospera test results for rejection
Timepoint [4] 0 0
6 months
Primary outcome [5] 0 0
Report calibrated Prospera test results for heart injury
Timepoint [5] 0 0
6 month
Secondary outcome [1] 0 0
Determine if Prospera blood test can replace heart biopsy test
Timepoint [1] 0 0
6 month
Secondary outcome [2] 0 0
Determine if Prospera blood test can replace follow up heart biopsy
Timepoint [2] 0 0
6 month
Secondary outcome [3] 0 0
Assessment of donor-specific antibody status
Timepoint [3] 0 0
6 months

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients will be excluded from the study if they decline participation
* Are unable to give informed consent.
* Recipients of multiple organs.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute - Darlinghurst
Recruitment postcode(s) [1] 0 0
NSW 2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Czechia
State/province [7] 0 0
Prague
Country [8] 0 0
Italy
State/province [8] 0 0
Bologna
Country [9] 0 0
Poland
State/province [9] 0 0
Zabrze
Country [10] 0 0
Spain
State/province [10] 0 0
La Coruna

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Natera, Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
One Lambda
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04707872
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.
Public notes

Contacts
Principal investigator
Name 0 0
Philip F Halloran, MD PhD
Address 0 0
Alberta Transplant Applied Genomics Center, University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Konrad Famulski, PhD
Address 0 0
Country 0 0
Phone 0 0
1 780 782 9463
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04707872