Cardiac Allograft Vasculopathy Clinical Trial
Official title:
Multiparametric Cardiac Positron Emission Tomography for Cardiac Allograft Vasculopathy Surveillance After Heart Transplantation
Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasive positron emission tomography (PET) based surveillance is non-inferior to invasive coronary angiography (ICA) surveillance.
MARINER is a Canadian multicentre prospective, randomized clinical outcomes-based trial evaluating noninferiority of a noninvasive PET strategy compared to ICA for CAV surveillance. Patients are randomized to annual PET or ICA for CAV surveillance. Non-inferiority is assessed according to a clinical composite of death, retransplant, allograft dysfunction not related to acute rejection, and angiographic CAV associated with myocardial infarction or heart failure. Secondary outcomes include the rate of new or progressive CAV, number of ICA performed, number of ICA and PET procedural related complications, EuroQol-5 Dimension assessed patient health-related quality of life and health care resource use. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02880137 -
Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy
|
Phase 4 | |
| Terminated |
NCT01848301 -
Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation
|
Phase 1 | |
| Terminated |
NCT01278745 -
Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation
|
Phase 2 | |
| Withdrawn |
NCT01812434 -
Phosphodiesterase-5 (PDE-5) Inhibition in Heart Transplant Recipients
|
N/A | |
| Withdrawn |
NCT01305382 -
Noninvasive Evaluation of Cardiac Allograft Vasculopathy
|
N/A | |
| Recruiting |
NCT05826444 -
Microvascular Cardiac Allograft Vasculopathy Trial
|
||
| Suspended |
NCT05756088 -
Determining the Association of Microvascular Disease as Assessed by PET and Graft Injury by Donor Derived Cell Free DNA
|
||
| Completed |
NCT02013037 -
The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
|
Phase 3 | |
| Withdrawn |
NCT01305395 -
Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients
|
N/A | |
| Withdrawn |
NCT01157949 -
A Study to Compare the Effectiveness of a Drug That Suppresses the Immune System Called Thymoglobulin® in Preventing the Development of a Disease That Affects the Majority of Heart Transplant Recipients Called Cardiac Allograft Vasculopathy (CAV)
|
Phase 3 | |
| Enrolling by invitation |
NCT06147271 -
Impact of SGLT2 Inhibitors in Heart Transplant Recipients
|
Phase 2 | |
| Recruiting |
NCT04193306 -
Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients
|
Phase 4 | |
| Recruiting |
NCT02798731 -
Physiologic Assessment of Microvascular Function in Heart Transplant Patients
|
||
| Withdrawn |
NCT02777255 -
Severe CAV MRI in Heart Transplant Recipient
|
N/A | |
| Completed |
NCT05373108 -
Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)
|
Phase 4 | |
| Withdrawn |
NCT01424917 -
Noninvasive Predictors of Transplant Vasculopathy
|
N/A | |
| Recruiting |
NCT04770012 -
AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
|
Phase 3 | |
| Active, not recruiting |
NCT01078363 -
Angiotensin Converting Enzyme (ACE) Inhibition and Cardiac Allograft Vasculopathy
|
N/A | |
| Completed |
NCT03734211 -
Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
|
Phase 3 | |
| Active, not recruiting |
NCT03386539 -
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
|
Phase 3 |