Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection (FreeDNA-CAR)

Majadahonda Iron Gate University

Status: Unknown

Conditions: Heart Transplant Rejection

Treatments: Diagnostic Test: Donor-derived cell Free DNA

Study type: Observational

Funder types: Other

Identifiers

NCT04973943

FreeDNA-CAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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