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Everolimus in de Novo Heart Transplant Recipients (EVERHEART)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017029
First Posted: November 20, 2009
Last Update Posted: January 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
November 19, 2009
November 20, 2009
December 10, 2014
December 18, 2014
January 12, 2015
September 2009
December 2013   (Final data collection date for primary outcome measure)
Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group [ Time Frame: 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
Any of the following complications after heart transplantation wound healing complications, pleural effusions (by chest X ray),pericardial effusions (by cardiac ultrasound),acute renal insufficiency by glomerular filtration rate(GFR)estimation. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT01017029 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    LDL = low density lipoprotein
  • Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group [ Time Frame: 6 months ]
    CMV infection is defined as pp65 antigenemia or DNAemia
  • Participants With at Least One Occurrence of Composite Treatment Failure Events [ Time Frame: 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
Proportion of patients with acute myocardial rejection (evaluated by endo-myocardial biopsy). [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Everolimus in de Novo Heart Transplant Recipients
Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Cardiac Transplantation
  • Drug: Everolimus
  • Drug: Mycophenolate mofetil + Everolimus
  • Active Comparator: Immediate introduction of everolimus
    Intervention: Drug: Everolimus
  • Experimental: Delayed introduction of everolimus
    delayed introduction) + Cyclosporin + steroids
    Intervention: Drug: Mycophenolate mofetil + Everolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01017029
CRAD001AIT16
2009-011008-43
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP