Heart Transplantation Clinical Trial
Official title:
A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06035991 -
First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System
|
N/A | |
Recruiting |
NCT01927614 -
Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy
|
N/A | |
Recruiting |
NCT01705015 -
Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
|
N/A | |
Completed |
NCT01655563 -
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
|
Phase 2 | |
Completed |
NCT01028599 -
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
|
N/A | |
Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
Terminated |
NCT00420537 -
Shift to Everolimus (RAD) Kidney Sparing Study
|
Phase 4 | |
Enrolling by invitation |
NCT03292861 -
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
|
Phase 2 | |
Recruiting |
NCT04924491 -
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
|
Phase 1/Phase 2 | |
Recruiting |
NCT05270902 -
Haemoadsorption During Heart Transplantation
|
N/A | |
Completed |
NCT05289180 -
Brachial Right Ventricle - Endomyocardial Biopsy
|
||
Recruiting |
NCT03687723 -
Observational Study of the Clinical Use of the OCS™ Heart
|
||
Completed |
NCT01091194 -
Effect of Exercise After Heart Transplantation
|
Phase 2 | |
Withdrawn |
NCT00780637 -
Brachial Artery t-PA Release in Heart Transplant Recipients
|
N/A | |
Completed |
NCT01182571 -
Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients
|
N/A | |
Withdrawn |
NCT00780377 -
Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients
|
N/A | |
Terminated |
NCT00678002 -
Quality of Life in Pediatric Transplant Patients
|
||
Withdrawn |
NCT00572286 -
Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study
|
N/A | |
Completed |
NCT00690157 -
Registry of Patients Referred for Heart Transplantation
|
N/A | |
Completed |
NCT00123331 -
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
|
Phase 4 |