Z94.1
Conditions
Interventions
Group 1: Arm 1 comprises the transplantation of a donor-derived radial forearm sentinel flap in heart transplant recipients, followed by standardized longitudinal monitoring. This includes serial clin
Sponsors
Klinik für Thorax- und Kardiovaskularchirurgie Herz- und Diabeteszentrum
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Indication for heart transplantation Clinically stable condition following heart transplantation Ability to understand the nature, significance, and implications of the study Presence of controlled comorbidities (e.g., hypertension, diabetes mellitus) not expected to significantly affect immune response or study outcomes Standard immunosuppressive therapy according to post–heart transplantation care is permitted
Exclusion criteria
Exclusion criteria: Known immunodeficiency or severe disorders of the immune system Uncontrolled systemic infections or active inflammatory diseases Severe additional organ failure significantly affecting postoperative outcomes Advanced peripheral vascular disease (e.g., relevant atherosclerosis) with increased risk of flap failure Participation in other experimental therapies within the last 6 months Prior organ transplantation Participation in clinical studies involving immunomodulatory or immunosuppressive interventions that may interfere with immune response assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the early detection of alloimmune activation or acute rejection following heart transplantation, as identified by histopathological changes in the donor-derived radial forearm sentinel flap. Assessments are performed at standardized follow-up time points in accordance with established heart transplant surveillance protocols (in particular at approximately 14-21 days postoperatively and at 3, 6, 9, and 12 months), as well as on an event-driven basis in case of clinical suspicion of rejection. Serial clinical evaluations and standardized punch biopsies of the sentinel flap are conducted and analyzed using histopathological, immunohistochemical, and molecular techniques. The findings are systematically correlated with conventional rejection diagnostics, particularly endomyocardial biopsy of the cardiac graft, to evaluate the sensitivity and potential temporal advantage of the sentinel flap for detecting alloimmune responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the evaluation of the temporal advantage of rejection detection in the sentinel flap compared to conventional diagnostics, particularly endomyocardial biopsy, as well as the correlation of histopathological, immunohistochemical, and molecular findings between the sentinel flap and the cardiac graft. In addition, the impact of sentinel flap–based diagnostics on clinical decision-making, particularly adjustments of immunosuppressive therapy, will be assessed. A further focus is the investigation of potential immunomodulatory effects of the radial forearm flap, including possible protective properties reflected by improved graft function and survival. Safety and morbidity of the procedure will also be evaluated, including surgical complications, biopsy-related risks, and vascular complications of the flap. Finally, the suitability of the sentinel flap as a minimally invasive, longitudinal monitoring tool for standardizing and objectifying rejection surveillance over a follow-up period of up to 24 months will be assessed. | — |
Countries
Germany
Contacts
Public ContactChristoph Wallner
Bergmannsheil Bochum
Outcome results
None listed