Everolimus in de Novo Heart Transplant Recipients (EVERHEART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01017029
First received: November 19, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Cardiac Transplantation
Drug: Everolimus
Drug: Mycophenolate mofetil + Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Proportion of patients with acute myocardial rejection (evaluated by endo-myocardial biopsy). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate introduction of everolimus Drug: Everolimus
Experimental: Delayed introduction of everolimus
delayed introduction) + Cyclosporin + steroids
Drug: Mycophenolate mofetil + Everolimus

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017029

Locations
Italy
Novartis Investigative Site
Origgio, Italy
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01017029     History of Changes
Other Study ID Numbers: CRAD001AIT16
Study First Received: November 19, 2009
Last Updated: March 6, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Mycophenolate mofetil
Everolimus
Sirolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014