Clinical Trials Logo

Clinical Trial Summary

Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood


Clinical Trial Description

Cardiac allograft vasculopathy (CAV) is a major limitation to longevity after heart transplantation (HT), accounting for almost 30% of deaths after year 5. The only cure is re-transplant which is associated with a 30-day mortality of 30%, and raises ethical issues due to limited resources. Standard preventive measures, such as statin therapy, have limited success due to the multi-factorial nature of the process and influence of transplant-specific risk factors. Consensus regarding the management of CAV is lacking due to the absence of prospective studies evaluating timing of initiation of therapy, effect of therapies on long-term outcomes, and effective diagnostic strategies. Primary prevention of CAV, which will be evaluated in the proposed study, could improve longevity of heart transplant recipients and optimize use of a limited resource.

The current gold standard for evaluation of CAV is surveillance coronary angiogram, which is highly insensitive, particularly in early disease. Intravascular ultrasound (IVUS) is the most sensitive tool for the diagnosis of CAV, providing specific information such as the appearance and thickness of the intima and media, however it is not widely used in the clinical setting. Physiologic studies of the coronary arteries are also useful in assessing risk, but are not practical in a clinical setting. These invasive studies expose the heart transplant recipient to radiation, nephrotoxic contrast, and potential vascular complications. During the evolution of CAV, there are important structural, functional, and genomic changes that occur in parallel and possibly before.

Study Objectives

1. Determine the structural, functional and genomic changes associated with severe CAV

2. Identify novel and noninvasive markers of CAV

Study Design This is a cross-sectional study which will evaluate structural, functional and genomic changes associated with severe CAV in heart transplant recipients within 15 years of transplant. 30 heart transplant recipients identified via our study database and the transplant clinic will be enrolled into the study. We will enroll 15 heart transplant patients with severe CAV and 15 without CAV.

Subjects will undergo a one-time assessment of radial artery elasticity, blood draw for gene expression profiles, and cardiac MRI. ;


Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02777255
Study type Observational
Source University of Minnesota - Clinical and Translational Science Institute
Contact
Status Withdrawn
Phase N/A
Start date May 2012
Completion date December 2014

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
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
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