Everolimus in de Novo Heart Transplant Recipients

Cardiac Transplantation Clinical Trial

— EVERHEART  

Official title:

Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017029
• Other study ID #: CRAD001AIT16
• Secondary ID: 2009-011008-43
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2009
• Last updated: December 23, 2014
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Transplantation

Intervention

Drug:
• Everolimus

• Mycophenolate mofetil + Everolimus

Locations

Country	Name	City	State
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Cagliari	CA
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Padova	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group	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	6 months	Yes
Secondary	Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group		6 months	Yes
Secondary	Hazard Cox's Model Analysis of Pericardial/Pleural Effusions	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	6 months	Yes
Secondary	Absolute and Percent Frequencies of Patients With LDL = 100 mg/mL at 1, 3 and 6 Months, by Treatment Group	LDL = low density lipoprotein	6 months	Yes
Secondary	Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group	CMV infection is defined as pp65 antigenemia or DNAemia	6 months	Yes
Secondary	Participants With at Least One Occurrence of Composite Treatment Failure Events	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	6 months	No