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NCT Number: NCT06942156

Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

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.

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Key information

Conditions

Heart Transplant

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Everolimus

Drug

Up to 1.5g BID(total 3g daily), PO - Check the blood concentration of Everolimus at each visit

Other names: Certirobell Tablet

Mycophenolate mofetil Tablet/Capsule

Drug

Up to 1.5g BID(total 3g daily), PO

Other names: Myrept® Cap./Tab.

Primary outcomes

  1. hierarchical composite assessed using the win-ratio

    Time frame: 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 outcomes

  1. Graft rejection

    Time frame: Baseline and 6, 12 months after drug administrations

    Time to onset of Graft rejection

  2. Newly developed Graft dysfunction

    Time frame: Baseline and 6, 12 months after drug administrations

    Frequency of incidence

  3. Change in renal function

    Time frame: Baseline and 6, 12 months after drug administrations

    Change in eGFR

  4. CAV ISHLT grade

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jin-O Choi, MD, PhD

CONTACT

[email protected]

02-3410-3419

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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

Acronym: OPTIMIZE-HTx

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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