Everolimus in de Novo Heart Transplant Recipients

Phase 4 Completed 182 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.

Timeline

Start: 2009-09
Primary completion: 2013-12
Completion: 2013-12

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper Incidence of primary safety endpoint was higher for EVR-I than EVR-D arm (44.9% vs 32.6%; P = 0.191), PMID 28930797 ↗

Publications

Potena L, Pellegrini C, Grigioni F, Amarelli C, Livi U, Maccherini M, Masciocco G, Faggian G, Lilla Della Monica P, Gerosa G, Marraudino N, Corda M, Boffini M; EVERHEART Investigators. Optimizing the Safety Profile of Everolimus by Delayed Initiation in De Novo Heart Transplant Recipients: Results of the Prospective Randomized Study EVERHEART. Transplantation. 2018 Mar;102(3):493-501. doi: 10.1097/TP.0000000000001945.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	—	—
Background	Mycophenolate Mofetil	Small molecule	—	—

Indications

No indication recorded.