At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 182 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)
In Brief
A Phase 4 clinical trial evaluating Everolimus and Mycophenolate mofetil + Everolimus for Cardiac Transplantation. Completed, enrolled 182 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Transplantation
CountriesItaly
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedNov 2009
Primary CompletionDec 2013
TodayJul 2026
First PostedNov 20, 2009
Enrollment StartSep 1, 2009
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.6 years ago
Interventions
Everolimusdrug
Mycophenolate mofetil + Everolimusdrug