Clinical trial NCT04973943: Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection
Official title: Donor-derived Cell Free DNA as a Potential New Biomarker in Cardiac Transplantation: Role in Acute Rejection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant Rejection
Keywords: Donor-derived cell Free DNA
Acute cellular rejection
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart transplant recipients aged 18 and over

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between dd-cfDNA levels and the presence of acute cellular rejection
timeFrame: 1 year
Secondary outcomes:
measure: Area under curve for dd-cfDNA
timeFrame: 1 year
measure: Correlation between dd-cfDNA and antibody mediated rejection (AMR)
timeFrame: 1 year
measure: Association between dd-cfDNA and immunosuppressive (IS) treatment
timeFrame: 1 year
measure: Association between dd-cfDNA (%) and left ventricular ejection fraction
timeFrame: 1 year
measure: Determine the biomarker's kinetics at 15 days post-transplant
timeFrame: 15 days
measure: Association between dd-cfDNA levels and cytomegalovirus (CMV) infection
timeFrame: 1 year
measure: Determine a cut-off point of dd-cfDNA that allows to differentiate between acute cellular rejection (ACR) and antibody mediated rejection (AMR)
timeFrame: 1 year
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Majadahonda
country: Spain
facility: University Hospital Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital 12 octubre
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References: