Everolimus in de Novo Heart Transplant Recipients

Phase 4

Completed

• Conditions: Cardiac Transplantation
• Interventions: Drug: Mycophenolate mofetil + Everolimus; Drug: Everolimus

• Registration Number: NCT01017029
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-10
• Results First Submitted QC: 2014-12-10
• Results First Posted: 2014-12-18
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed introduction of everolimus	Mycophenolate mofetil + Everolimus	delayed introduction) + Cyclosporin + steroids
Immediate introduction of everolimus	Everolimus	-

Primary Outcome Measures

Name	Time	Method
Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group	6 months	Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm

Secondary Outcome Measures

Name	Time	Method
Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group	6 months
Hazard Cox's Model Analysis of Pericardial/Pleural Effusions	6 months	Pericardial effusions: any pericardial effusion defined as at least moderate (i.e. measuring at least 2.0 cm in diastole, in the point of largest distance between the pericardial leaflets), with or without signs of hemodynamic compromise, or leading to drainage or to prolonged hospitalization. Pleural effusions: need for surgical drainage tubes for longer than 7 days after surgery and subsequent pleural effusions leading to drainage. CI = confidence interval, HR = hazard ratio, MDRD = Modification of Diet in Renal Disease
Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group	6 months	LDL = low density lipoprotein
Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group	6 months	CMV infection is defined as pp65 antigenemia or DNAemia
Participants With at Least One Occurrence of Composite Treatment Failure Events	6 months	Comparison of 6-months cumulative incidence of composite treatment failure events (BPAR ≥ 2R, rejection with hemodynamic compromise, graft loss, or death) between delayed everolimus arm and immediate everolimus arm

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Napoli, Italy