Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection
NCT ID: NCT04973943
Last Updated: 2021-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2019-03-19
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Donor-derived cell Free DNA
Measurement of dd-cfDNA and comparison against grade of rejection as determined by endomyocardial biopsy, taken simultaneously
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients on invasive mechanical ventilation 15 days after heart transplant
* Patients on renal replacement therapy, continuous or periodic, 15 days after heart transplant
* Heart Transplant due to a cardiomyopathy that could potentially recur on the graft (cardiac amyloidosis, Chagas disease or sarcoidosis, amongst others)
* Multiorgan transplant
18 Years
ALL
No
Sponsors
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Puerta de Hierro University Hospital
OTHER
Responsible Party
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Javier Segovia Cubero
Head of Cardiology Department
Locations
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University Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Bellvitge
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital 12 octubre
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Javier Segovia Cubero, MD PhD
Role: backup
References
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Jimenez-Blanco M, Crespo-Leiro MG, Garcia-Cosio Carmena MD, Gomez Bueno M, Lopez-Vilella R, Ortiz-Bautista C, Farrero-Torres M, Zegri-Reiriz I, Diaz-Molina B, Garcia-Romero E, Rangel-Sousa D, Salterain N, Garrido Bravo I, Segovia-Cubero J. Donor-derived cell-free DNA as a new biomarker for cardiac allograft rejection: A prospective study (FreeDNA-CAR). J Heart Lung Transplant. 2025 Apr;44(4):560-569. doi: 10.1016/j.healun.2024.11.009. Epub 2024 Nov 20.
Other Identifiers
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FreeDNA-CAR
Identifier Type: -
Identifier Source: org_study_id
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