Heart Transplant Rejection Clinical Trial
Official title:
A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation
This study is a prospective, observational multi-center cohort study. The study will consist of patients undergoing heart transplantation. The main purpose is to test a new biomarker for rejection against the gold-standard, the endomyocardial biopsy (EMB). 80 patients will be included, both children and adults.
The primary objective is a comparison of an the established, invasive diagnostic test, the endomyocardial biopsy (EMB) against a new, non-invasive test. The new test is the measurement of donor-derived cell-free DNA (dd-cfDNA) circulating in the blood stream of the recipient, quantified by droplet digital PCR (polymerase-chain reaction) after targeted multiplex preamplification. Sensitivity is calculated with EMB as the gold standard. The patients will be followed during one year post-transplantation with simultaneous blood samples and EMB. The patients will further be followed clinically for 5 years. A suitable cut-off for the ratio of dd-cfDNA will be calculated using receiver operating characteristic (ROC) analysis. Secondary objectives are description of patient outcomes with respect to organ function, quality of life and adverse events. Secondary objectives are the calculation of the costs related to the transplantation process as well as to the follow-up with EMB. A simulation will be done with respect to possible savings achieved if the new biomarker could be implemented. The study consists of two cohorts: all adult recipients of heart transplantation at Sahlgrenska University Hospital (one of two center conducting heart transplantation in Sweden): regional study. The other cohort consists of all children undergoing heart transplantation in Sweden:national study. Patients will undergo transplantation at Sahlgrenska University Hospital in Gothenburg as well as at Skåne University Hospital in Lund. Follow-up with blood samples and EMB of these patients will be in Gothenburg, Lund and at Karolinska University Hospital in Stockholm. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05205551 -
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
|
||
| Completed |
NCT06436027 -
Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.
|
||
| Not yet recruiting |
NCT05732779 -
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
|
N/A | |
| Active, not recruiting |
NCT05064462 -
TTV Viral Load in Heart Transplant Recipients
|
||
| Recruiting |
NCT04973943 -
Donor-derived Cell Free DNA as a New Biomarker in Cardiac Acute Rejection
|
||
| Not yet recruiting |
NCT05772442 -
Cardiac Transplant Metabolomics With and Without Rejection
|
||
| Recruiting |
NCT04707872 -
Trifecta-Heart cfDNA-MMDx Study
|
||
| Recruiting |
NCT06064123 -
Biomarkers for Diagnosis, Prognosis, and Targeted Therapy After Heart Transplantation
|
||
| Active, not recruiting |
NCT04921774 -
Research on Patients With Heart Transplantation
|
||
| Recruiting |
NCT04226521 -
Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy
|
N/A | |
| Completed |
NCT03393793 -
HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
|
||
| Completed |
NCT01136135 -
Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Cardiac Transplant Rejection
|
N/A | |
| Completed |
NCT03833050 -
The TOGETHER Project - Heart
|
||
| Active, not recruiting |
NCT03373227 -
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen
|
Phase 2 | |
| Active, not recruiting |
NCT03695601 -
Surveillance HeartCare® Outcomes Registry
|
||
| Active, not recruiting |
NCT01397812 -
Heartsbreath Test for Heart Transplant Rejection
|
N/A | |
| Active, not recruiting |
NCT05184426 -
MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
|