Everolimus in de Novo Heart Transplant Recipients (EVERHEART)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01017029
First received: November 19, 2009
Last updated: July 17, 2014
Last verified: July 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 4

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 ]

Enrollment: 182
Study Start Date: September 2009
Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Novartis Investigative Site
Bari, BA, Italy, 70124
Novartis Investigative Site
Bologna, BO, Italy, 40138
Novartis Investigative Site
Cagliari, CA, Italy, 09134
Novartis Investigative Site
Milano, MI, Italy, 20162
Novartis Investigative Site
Padova, PD, Italy, 35128
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Roma, RM, Italy, 00152
Novartis Investigative Site
Siena, SI, Italy, 53100
Novartis Investigative Site
Torino, TO, Italy, 10126
Novartis Investigative Site
Udine, UD, Italy, 33100
Novartis Investigative Site
Verona, VR, Italy, 37126
Novartis Investigative Site
Napoli, Italy, 80131
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01017029     History of Changes
Other Study ID Numbers: CRAD001AIT16, 2009-011008-43
Study First Received: November 19, 2009
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on October 16, 2014