Clinical trial NCT01017029: Everolimus in de Novo Heart Transplant Recipients
Official title: Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion criteria:

* Male or female cardiac transplant candidates 18-65 years of age undergoing primary heart transplantation.
* Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization

Exclusion criteria:

* Patients who are recipients of multiple solid organ transplants
* Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive;
* Presence of Donor/Recipients serological mismatch for Hepatitis B or C;
* Recipients of organ from donors positive for Hepatitis B-surface antigen;
* Panel Reactive Antibodies (cytotoxicity method) \> 30%.
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group
timeFrame: 6 months
Secondary outcomes:
measure: Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group
timeFrame: 6 months
measure: Hazard Cox's Model Analysis of Pericardial/Pleural Effusions
timeFrame: 6 months
measure: Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group
timeFrame: 6 months
measure: Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group
timeFrame: 6 months
measure: Participants With at Least One Occurrence of Composite Treatment Failure Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Padova
country: Italy
facility: Novartis Investigative Site
state: PD
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Siena
country: Italy
facility: Novartis Investigative Site
state: SI
city: Torino
country: Italy
facility: Novartis Investigative Site
state: TO
city: Udine
country: Italy
facility: Novartis Investigative Site
state: UD
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Napoli
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.