Deuse, Tobias and Bara, Christoph and Barten, Markus J. and Hirt, Stephan W. and Doesch, Andreas O. and Knosalla, Christoph and Grinninger, Carola and Stypmann, Joerg and Garbade, Jens and Wimmer, Peter and May, Christoph and Porstner, Martina and Schulz, Uwe (2015) The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation. CONTEMPORARY CLINICAL TRIALS, 45. pp. 356-363. ISSN 1551-7144, 1559-2030
Full text not available from this repository. (Request a copy)Abstract
In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. (C) 2015 Elsevier Inc. All rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CARDIAC ALLOGRAFT VASCULOPATHY; CALCINEURIN INHIBITOR WITHDRAWAL; CYTOMEGALOVIRUS-INFECTION; RENAL-FUNCTION; MYCOPHENOLATE-MOFETIL; RISK-FACTORS; SDZ RAD; RECIPIENTS; CYCLOSPORINE; SIROLIMUS; MANDELA; Everolimus; Randomized; Heart; Transplantation |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 06 May 2019 08:25 |
| Last Modified: | 06 May 2019 08:25 |
| URI: | https://pred.uni-regensburg.de/id/eprint/4499 |
Actions (login required)
 |
View Item |
