Cardiac Allograft Vasculopathy Clinical Trial
Official title:
Impact of Endothelin-1 on the Development of Cardiac Allograft Vasculopathy in Heart Transplant Recipients: Endothelin Receptor Antagonism and Vasomotor Function
Many patients with end-stage heart failure, a condition in which the heart fails to pump enough blood to support the body's other organs, are fortunate enough to receive a heart transplant. However, despite taking medicines aimed at blunting the immune system's response to the donor heart, some of them will develop transplant-related disease in the coronary arteries supplying their hearts. Fifty years after the first human-to-human heart transplant, this disorder-cardiac allograft vasculopathy (CAV)-remains a leading cause of long-term death and has been coined the 'Achilles' Heel' of heart transplantation. Indeed, a better understanding of how CAV occurs and improved therapies to prevent and/or slow its development are desperately needed to meaningfully impact patient outcomes. Endothelin-1 (ET-1) is a key molecular regulator of arterial health, and our prior data suggests that it is associated with accelerated CAV. In this particular study of recent heart transplant recipients, we are asking: Does ET-1 contribute to the coronary artery's capacity to dilate/constrict? To answer this question, during the cardiac catheterization at 1 year post-transplant (standard of care), we will measure blood levels of ET-1 and perform an invasive evaluation of coronary vasomotor function inn a consecutive subset of patients who will have received a 1-week course of the oral endothelin receptor antagonist (macitentan) prior this catheterization, which will allow us to test how much ET-1 contributes to coronary responsiveness. The findings from this study may provide the necessary foundation to study whether endothelin receptor antagonists are able to effectively reduce the rate of accelerated CAV.
n/a
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Withdrawn |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 |
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 | |
Withdrawn |
NCT01305395 -
Strategies To Prevent Cardiac Allograft Vasculopathy Related Events in Heart Transplant Recipients
|
N/A | |
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 | |
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 | |
Recruiting |
NCT06089486 -
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
|
N/A | |
Active, not recruiting |
NCT03386539 -
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
|
Phase 3 |