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Everolimus in de Novo Heart Transplant Recipients (EVERHEART)

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. Identifier: NCT01017029
Recruitment Status : Completed
First Posted : November 20, 2009
Results First Posted : December 18, 2014
Last Update Posted : January 12, 2015
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Transplantation Drug: Everolimus Drug: Mycophenolate mofetil + Everolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : September 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Active Comparator: Immediate introduction of everolimus Drug: Everolimus
Experimental: Delayed introduction of everolimus
delayed introduction) + Cyclosporin + steroids
Drug: Mycophenolate mofetil + Everolimus

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group [ Time Frame: 6 months ]
  2. 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

  3. 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

  4. 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

  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017029

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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01017029    
Other Study ID Numbers: CRAD001AIT16
First Posted: November 20, 2009    Key Record Dates
Results First Posted: December 18, 2014
Last Update Posted: January 12, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Mycophenolic Acid
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action