Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05373108
Study type Interventional
Source University of California, Los Angeles
Contact
Status Completed
Phase Phase 4
Start date May 19, 2022
Completion date February 14, 2023

See also
  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Withdrawn NCT01812434 - Phosphodiesterase-5 (PDE-5) Inhibition in Heart Transplant Recipients N/A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
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