Everolimus in de Novo Heart Transplant Recipients

Novartis Pharmaceuticals182 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

182

Conditions

Cardiac Transplantation

Interventions

EverolimusDRUG

Mycophenolate mofetil + EverolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (12)

Novartis Investigative Site

Bari, BA, Italy

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Cagliari, CA, Italy

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group

Time frame: 6 months

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

Time frame: 6 months

Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group

LDL = low density lipoprotein

Time frame: 6 months

Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group

CMV infection is defined as pp65 antigenemia or DNAemia

Time frame: 6 months

Participants With at Least One Occurrence of Composite Treatment Failure Events

Data from ClinicalTrials.gov

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