Conditions: Heart Diseases Heart Transplantation
Keywords: Antirejection Treatment Outcome Immunosuppression Treatment Effectiveness Anti-rejection therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 111
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Detailed description:
Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant

Two parallel active arms.

Arms:
arm 1: Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 2: Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 3: Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant arm 4: Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant

Interventions: intervention 1: Tacrolimus intervention 2: Cyclosporine intervention 3: Mycophenolate mofetil intervention 4: Methylprednisolone intervention 5: Prednisone
Intervention descriptions: intervention 1: Oral intervention 2: Oral intervention 3: Intravenous and Oral intervention 4: Intravenous intervention 5: Oral

Protocol document: