Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
182 participants
INTERVENTIONAL
2009-09-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
NCT00154297
Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients
NCT00150046
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
NCT01266148
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
NCT00170859
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
NCT00134940
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immediate introduction of everolimus
Everolimus
Delayed introduction of everolimus
delayed introduction) + Cyclosporin + steroids
Mycophenolate mofetil + Everolimus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Everolimus
Mycophenolate mofetil + Everolimus
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization
Exclusion Criteria
* 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%.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Bari, BA, Italy
Novartis Investigative Site
Bologna, BO, Italy
Novartis Investigative Site
Cagliari, CA, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Pavia, PV, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Siena, SI, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Udine, UD, Italy
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Napoli, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-011008-43
Identifier Type: -
Identifier Source: secondary_id
CRAD001AIT16
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.