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Everolimus in de Novo Heart Transplant Recipients (EVERHEART)

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01017029
First received: November 19, 2009
Last updated: April 28, 2012
Last verified: April 2012
History of Changes

November 19, 2009
April 28, 2012
September 2009
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01017029 on ClinicalTrials.gov Archive Site
Proportion of patients with acute myocardial rejection (evaluated by endo-myocardial biopsy). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
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 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
200
Not Provided
July 2012   (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
Both
18 Years to 65 Years
No
Contact: Novarts Pharmaceuticals 862-778-8300
Italy
 
NCT01017029
CRAD001AIT16
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2012

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