The purpose of this study is to evaluate the efficacy and safety of lower dose calcineurin inhibitors (CNI) in combination with Everolimus in Korean heart transplant recipients.
Over 19 years old
Patients with stable heart transplant graft function at least 28~100 days post transplant.
Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion
Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ.
Recipients of heart from ABO-incompatible donor
Recipients of heart from the donor aged 70 or older
Parallel
Everolimus
DrugUp to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit
Mycophenolate mofetil Tablet/Capsule
DrugUp to 1.5g BID(total 3g daily), PO
hierarchical composite assessed using the win-ratio
hierarchical composite assessed using the win-ratio, including graft survival, treated rejection episodes, change in percent atheroma volume, and change in eGFR.
Graft rejection
Time to onset of Graft rejection
Newly developed Graft dysfunction
Frequency of incidence
Change in renal function
Change in eGFR
CAV ISHLT grade
Coronary Arterial Vasculopathy(CAV) assessed by ISHLT grade for CAV (ISHLT: International Society for Heart and Lung Transplantation) * CAV0 (Not significant): No detectable angiographic lesion * CAV1 (Mild): Angiographic LM\<50% or Primary vessel with maximum lesion\<70% or Branch stenosis\<70% * CAV2 (Moderate): Angiographic LM\<50%, Single primary vessel≥70% or Isolated branch stenosis in 2 system≥70% * CAV3 (Severe): Angiographic LM≥50% or ≥2 primary vessels ≥70% or Isolated branch stenosis in all 3 system≥70% or CAV1 or CAV2 with allograft dysfunction (LVEF≤45%) or evidence of significant restrictive physiology
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This trial is not recruiting at the moment. You can still explore other options:
