Heart Transplant
Conditions
Keywords
Heart transplant, Everolimus
Brief summary
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.
Detailed description
This study is a prospective, multicenter, open-label, randomized, comparative, phase 4 trial to optimize immunosuppressive therapy using everolimus and low-dose calcineurin inhibitors in heart transplant patients in Korea.
Interventions
DRUGEverolimus
Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit
Up to 1.5g BID(total 3g daily), PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 19 years old 2. Patients with stable heart transplant graft function at least 28\ 100 days post transplant. 3. Patients who are appropriate for combination therapy with Everolimus and Calcineurin inhibitor (CNI) at the investigator's discretion
Exclusion criteria
1. Recipients who have had a prior organ transplant, or who underwent a heart transplant with the simultaneous transplantation of another organ. 2. Recipients of heart from ABO-incompatible donor 3. Recipients of heart from the donor aged 70 or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hierarchical composite assessed using the win-ratio | baseline, 12 months | hierarchical composite assessed using the win-ratio, including graft survival, treated rejection episodes, change in percent atheroma volume, and change in eGFR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in renal function | Baseline and 6, 12 months after drug administrations | Change in eGFR |
| Graft rejection | Baseline and 6, 12 months after drug administrations | Time to onset of Graft rejection |
| Newly developed Graft dysfunction | Baseline and 6, 12 months after drug administrations | Frequency of incidence |
| CAV ISHLT grade | Until 12 months | 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 |
Countries
South Korea
Contacts
Primary ContactJin-O Choi, MD, PhD
Outcome results
None listed