View clinical trials related to Cardiac Transplantation.
Filter by:Heart transplantation is the gold standard treatment for advanced heart failure, with a survival rate >60% at 10 years. Heart transplantation activity has tended to decline significantly in France since 2017, with -5% of transplants per year according to the Agence de la Biomédecine report (La Plaine-Saint-Denis, France, https://rams.agence-biomedecine.fr). Graft selection criteria have been extended over the past two decades, in particular the average donor age, which currently exceeds 50 in France. These donors with extended criteria are more exposed to the risk of acquired coronary lesions. The current indications for donor coronary angiography are age >55 or >45 with at least two cardiovascular risk factors, but it is performed in only a third of these cases. Coronary angiography would increase the chances of graft acceptance by 9%. At the same time, some heart transplants are rejected for lack of a complete functional evaluation, or because they present moderate left ventricular dysfunction. In catecholaminergic stress cardiomyopathy, left ventricular dysfunction is reversible, but its recovery kinetics are difficult to predict. Ex vivo resuscitation of these grafts on a perfusion machine could enable functional recovery and acceptance of these grafts for transplantation. This approach could also be applied to other cardiac grafts harvested from donors with extended criteria, such as prolonged cardiac arrest. Graft preservation on ex vivo perfusion machines has enjoyed considerable growth over the past decade. The Organ Care System (OCS, TransMedics, Andover, USA) is currently the only transportable perfusion machine available and marketed for clinical use, with experience of over 1,000 transplants worldwide. OCS technology is based on isolated ex vivo perfusion of the heart with normothermic blood in Langendorff mode (retrograde aortic perfusion). This transportable platform enables metabolic evaluation of the graft based on the concentration of circulating lactate in the perfusate, a criterion of viability and "transplantability". The aims of this alternative method to static hypothermic preservation of heart grafts are threefold: 1) to extend the preservation time of the heart graft; 2) to assess graft viability prior to transplantation; 3) to resuscitate a heart graft harvested after controlled circulatory arrest (Maastricht 3). Since February 2019, 31 heart grafts have been placed on OCS in France thanks to the implementation of an ex vivo perfusion program at the Lille and Rennes teaching hospitals, and the Marie Lannelongue Hospital. Our preliminary results have recently been accepted for publication. In this research project, we propose to analyze in real time the quality of coronary perfusion using vasculoscopy on isolated human hearts placed on OCS, and to put this anatomical and functional assessment into perspective with the results of heart transplantation. Indeed, vasculoscopy is an innovative non-invasive imaging approach that has never before been applied in the cardiovascular field. We aim to validate this technology in the assessment of myocardial perfusion quality of the machine-perfused graft awaiting transplantation, by correlating the signal obtained with perfusion parameters on OCS (coronary flow, mean aortic pressure, arterial and venous lactate) as well as with transplant outcomes (primary graft failure rate, recipient survival rate at one month post-transplant). Myocardial perfusion parameters have never been correlated with heart transplantation outcomes to date.
There are several factors initiating cytokine storm and dysregulated systemic inflammatory response during cardiac transplantation. This may lead to serious perioperative complications: circulatory collapse, respiratory insufficiency, acute renal and liver failure, multi-organ dysfunction etc. On the other hand the high level of cytokines may play an important role in the development of graft rejection which is still a relevant problem in this patient group. There are some new data showing that the use of extracorporeal cytokine adsorber during long cardiopulmonary bypass time (>120min) may be beneficial to prevent SIRS (Systemic Inflammatory Response Syndrome) with decreasing the level of cytokines in patients undergoing elective cardiac surgery. However there is lack of data and studies regarding the effect of extracorporeal cytokine adsorption during cardiac transplantation. The aim of the study is to investigate the effect of extracorporeal cytokine adsorber built in the cardiopulmonary bypass circle during heart transplantation. The hypothesis is that removal of cytokines during heart transplantation prevents the development of extreme systemic inflammatory response, hemodynamic collapse dominated by vasoplegia, and contribute to reduce the incidence of severe perioperative complications and early graft rejection.
The purpose of this study is to evaluate the level of expression of 4 circulating microRNAs in the serum using RT-PCR. A pilote study with cardiac transplant patients has shown that expression of these microRNAs could discriminate patients with a histologically proven rejection from patient displaying a normal endomyocardial biopsy. The signature must be confirmed in unselected patients and its stability evaluated according to clinical, biological and immunological parameters of included patients.
This study is a multicenter, non-randomized, retrospective study to collect long term (4 years post-transplant) clinical outcome data on subjects previously enrolled in the CTOT-05 study (NCT00466804) to evaluate participant and graft survival.
The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. In terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.
Heart transplant is a recognized therapeutic strategy in refractory heart failure. Its success is however hampered by severe cancer occurrence and recurrence. The new m-tor inhibiting drugs Sirolimus and Everolimus have shown potential for reducing the incidence of cancer in animal models. They are potent immunosuppressant, antiproliferative and antiangiogenic drugs. This open labelled randomized multicenter study aims at evaluating the beneficial antineoplastic effect of Everolimus in 159 heart transplant patients suffering of recurrent skin cancer. Primary objective is to demonstrate a reduction in the number of new skin cancers. Secondary end point will be time of recurrence, incidence of non skin cancer, graft function following switch (including death), renal function evolution following calcineurin inhibitors reduction or withdrawal, Everolimus tolerance profile, schemes of calcineurin inhibitors reduction management in centers.
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials. This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on : - Renal function improvement - Vasculopathy and major cardiac event reduction - Maintenance of immunosuppressive efficacy
In this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.
The goal of this study is to detect AR and CR in the transplanted heart by quantitative assessment of myocardial blood flow and its constituents by myocardial contrast echocardiography (MCE). Further we investigate the collateral circulation in these patients.