Everolimus in de Novo Heart Transplant Recipients (EVERHEART)

Novartis

Status and phase: Completed; Phase 4

Conditions: Cardiac Transplantation

Treatments: Drug: Everolimus; Drug: Mycophenolate mofetil + Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017029

CRAD001AIT16

2009-011008-43

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Immediate introduction of everolimus

Active Comparator group

Treatment:

Drug: Everolimus

Delayed introduction of everolimus

Experimental group

Description:

delayed introduction) + Cyclosporin + steroids

Treatment:

Drug: Mycophenolate mofetil + Everolimus