NCT04973943

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

March 15, 2021

Last Update Submit

July 20, 2021

Conditions

Heart Transplant Rejection

Keywords

Donor-derived cell Free DNAAcute cellular rejection

Outcome Measures

Primary Outcomes (1)

  • Association between dd-cfDNA levels and the presence of acute cellular rejection

    Association between dd-cfDNA levels above a certain cut-point and the presence of treatable acute cellular rejection as determined by endomyocardial biopsy (graded by International Society of Heart and Lung Transplantation 2010 classification, grade \> 1R).

    1 year

Secondary Outcomes (7)

  • Area under curve for dd-cfDNA

    1 year

  • Correlation between dd-cfDNA and antibody mediated rejection (AMR)

    1 year

  • Association between dd-cfDNA and immunosuppressive (IS) treatment

    1 year

  • Association between dd-cfDNA (%) and left ventricular ejection fraction

    1 year

  • Determine the biomarker's kinetics at 15 days post-transplant

    15 days

  • +2 more secondary outcomes

Interventions

Donor-derived cell Free DNADIAGNOSTIC_TEST

Measurement of dd-cfDNA and comparison against grade of rejection as determined by endomyocardial biopsy, taken simultaneously

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart transplant recipients aged 18 and over

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Universitario A Coruña

A Coruña, Spain

RECRUITING

Hospital Bellvitge

Barcelona, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

RECRUITING

Hospital Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital 12 octubre

Madrid, Spain

RECRUITING

Hospital Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Virgen del Rocio

Seville, Spain

RECRUITING

Hospital La Fe

Valencia, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39577511DERIVED

Central Study Contacts

Marta B Jimenez-Blanco Bravo, MD

CONTACT

0034 637747916martajbb@gmail.com

Javier Segovia Cubero, MD PhD

CONTACT

jsecu@telefonica.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology Department

Study Record Dates

First Submitted

March 15, 2021

First Posted

July 22, 2021

Study Start

March 19, 2019

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

ES(12)