Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection

NCT ID: NCT04973943

Last Updated: 2021-07-22

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-19

Study Completion Date

2022-04-30

Brief Summary

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FreeDNA-CAR is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (HT) patients from 14 centers in Spain. Our main objective is to test donor-derived Cell-Free DNA (dd-cfDNA) against endomyocardial biopsy (EMB) for the diagnosis of acute cellular rejection.

Detailed Description

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All patients will be enrolled immediately after HT, and will undergo undergo routine surveillance EMB at 15 days, 1 month, 2, 3, 4, 6 and 12 months after HT. Simultaneously with each EMB, dd-cfDNA will be measured in plasma.

Conditions

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Heart Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years old who undergo heart transplant during the recruiting period

Exclusion Criteria

* Patients with moderate or severe Primary Graft Dysfunction
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Puerta de Hierro University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Javier Segovia Cubero

Head of Cardiology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status RECRUITING

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status RECRUITING

Hospital Universitario A Coruña

A Coruña, , Spain

Site Status RECRUITING

Hospital Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital 12 octubre

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Hospital Virgen de la Arrixaca

Murcia, , Spain

Site Status RECRUITING

Hospital Virgen del Rocio

Seville, , Spain

Site Status RECRUITING

Hospital La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Marta B Jimenez-Blanco Bravo, MD

Role: CONTACT

0034 637747916

Javier Segovia Cubero, MD PhD

Role: CONTACT

Facility Contacts

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Marta Jimenez-Blanco Bravo, MD

Role: primary

0034637747916

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.

Reference Type DERIVED
PMID: 39577511 (View on PubMed)

Other Identifiers

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FreeDNA-CAR

Identifier Type: -

Identifier Source: org_study_id

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