NCT04973943

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

Donor-derived Cell Free DNA as a Potential New Biomarker in Cardiac Transplantation: Role in Acute Rejection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Transplant Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Donor-derived cell Free DNA	Measurement of dd-cfDNA and comparison against grade of rejection as determined by endomyocardial biopsy, taken simultaneously

Timeline

• Start date: 2019-03-19
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-07-22
• Last updated: 2021-07-22

Locations

12 sites across 1 country: Spain