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Cardiac Allograft Vasculopathy clinical trials

View clinical trials related to Cardiac Allograft Vasculopathy.

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NCT ID: NCT06089486 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05826444 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Microvascular Cardiac Allograft Vasculopathy Trial

mCAV
Start date: October 1, 2022
Phase:
Study type: Observational

The aim of the mCAV study is a comprehensive characterization of the genetic, morphological and functional phenotype of isolated microvascular graft vasculopathy (mCAV) after orthotopic heart transplantation (OHT). The utilized methods include dynamic echocardiography, magnetic resonance imaging, invasive microvascular resistance measurements, histology, cellular calcium-signaling and magnetocardiography as well as molecular genetic expression analysis.

NCT ID: NCT04770012 Recruiting - Heart Transplant Clinical Trials

AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Start date: June 28, 2021
Phase: Phase 3
Study type: Interventional

Cardiac allograft vasculopathy is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. The research team is investigating whether early antiplatelet therapy post heart transplant can prevent the development of CAV. This study will determine the feasibility of a large multicenter randomized placebo-controlled trial to answer this question.

NCT ID: NCT04226521 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy

ECP-OCT
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Heart transplantation is a golden standard for the treatment of terminal heart failure. The major cause of death in late posttransplant period is cardiac allograft vasculopathy (CAV). This posttransplant complication develops slowly over several years, and when diagnosed either by conventional coronary angiography or due to graft failure, it is often too advanced and difficult to treat since it is diffuse coronary artery disease. Therefore, early prevention of CAV is a subject of major interest in the transplant cardiology. Since CAV is associated with immune factors, immunomodulatory therapeutic options, like extracorporeal photopheresis are lately being investigated. Unlike conventional coronary angiography, optical coherence tomography (OCT) is able to detect the development of CAV in the earliest phase, i.e. even in the first post-transplant year. In our study, we plan to investigate the prophylactic effect of extracorporeal photopheresis in the early development of cardiac graft vasculopathy detected by OCT.

NCT ID: NCT04193306 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients

ACAV
Start date: November 18, 2019
Phase: Phase 4
Study type: Interventional

Cardiac allograft vasculopathy (CAV) represents the leading cause of late morbidity and mortality in heart transplant recipients as the second most frequent cause of all deaths at 3 years. In distinction from general coronary atherosclerosis, CAV affects diffusely the entire coronary vasculature with marked intimal proliferation and concentric vascular thickening and fibrosis. It was demonstrated that most of the intimal thickening due to CAV occurs during the first year after transplantation. Furthermore, the severity of the CAV appears to correlate with lipid abnormalities and elevated low-density lipoprotein cholesterol (LDL-C) is very common after transplantation with nadir of LDL levels occurring at 6 months. Because of drug-drug interactions, heart transplant recipients cannot be treated with adequate doses of statins to achieve desirable reduction of LDL-C levels (reduction ˂ 60% of LDL-C). The use of alternative lipid-lowering drugs including bile acid sequestrates, fibrates, nicotinic acid or ezetimibe is not recommended in post-transplant scenario. Inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) increase availability has emerged as a novel drug tool for LDL-C lowering, capable to lower LDL-C by more than 60% even in statin-treated patients with very good safety profile. Although heart transplant recipients fulfill approved indication and standard clinical guidelines of a PCSK9 inhibitor, alirocumab, there are no available data on use of PCSK9 inhibitor in post-transplant situation. The purpose of the ACAV study is to clarify efficacy and safety of alirocumab compared to placebo administered during the first year after transplantation in heart transplant recipients in addition to background atorvastatin therapy. Except lipid profile, optical coherence tomography (OCT) will be performed as the objective efficacy endpoint to examine thickness and lumen of coronary vessels. It is expected that inhibition of PCSK9 in heart transplant recipient will dramatically improve post-transplant lipoprotein levels and perhaps slow down development of CAV in the most critical period of the first year after transplantation.

NCT ID: NCT03808324 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Heart Failure After Heart Transplantation Due to Chronic Rejection

AVALON
Start date: January 2019
Phase: N/A
Study type: Interventional

This study will investigate the prevalence of allograft vasculopathy and unexplained graft dysfunction during long-term follow-up after heart transplantation. Risk factors as well diagnostic approaches will be investigated.

NCT ID: NCT03405831 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Effect of Ivabradine on Exercise Capacity After Heart Transplantation

VANISH-CAV
Start date: April 17, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates whether treatment with ivabradine compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart rate at rest. Patients will receive treatment with either ivabradin or placebo for a period of 12 weeks.

NCT ID: NCT02798731 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Physiologic Assessment of Microvascular Function in Heart Transplant Patients

Start date: May 2016
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to evaluate the impact of early microvascular disease assessed by coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve (CFR), index of microvascular resistance (IMR) on future occurrence of cardiac allograft vasculopathy (CAV) in heart transplant recipients.

NCT ID: NCT00966836 Recruiting - Clinical trials for Heart Transplantation

Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy

PROTECT
Start date: April 2009
Phase: Phase 3
Study type: Interventional

Cardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart transplant recipients. Although several immune-mediated and metabolic risk factors have been implicated in the pathogenesis of CAV, no effective therapy is currently available to treat established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is based on prevention and treatment of factors known to trigger its development. Although the mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV progression. Two strategies involving administration of specific anti-CMV agents are recommended for prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros and cons of the two strategies are still debated, in the absence of randomized studies addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear evidence of superiority of either approach. The investigators conceived this randomized prospective project to compare the effect of preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on one-year increase in coronary intimal thickening. Patients will be additionally randomized to receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV properties of everolimus.