View clinical trials related to Heart Transplantation.
Filter by:Context Cytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients. Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy. As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France). Aim of the study The aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy. Methods Participation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL. The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation). - In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices. - in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive. In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect). The participants will be sampled: - 5 to 12 days after QF-CMV sampling (V2) ; - 7 to 14 days days after V2 (V3 - between D12 and D26) ; - 7 to 14 days days after V3 (V4 - between D19 and D40) . Endpoints The primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows: - Blood CMV viral load >10,000 IU/mL [4 log]; - And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise >5000 IU/mL; - And/or the onset of CMV disease. The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).
There are many barriers to heart-healthy lifestyles in pediatric patients with acquired and congenital heart disease. Investigators want to further understand how participants heart and skeletal muscles work together during exercise and evaluate the impact on cardiac function. To do this, the investigators will use magnetic resonance imaging (MRI) to scan the heart and skeletal muscles during exercises to assess blood flow, oxygenation and function.
The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion device. This recovery of cardiac function will have to happen within 15 days after transplantation.
A cross-sectional analysis of 200 heart transplant recipients, combining in-depth phenotyping and risk factor assessment (cardiac MRI, coronary angiogram with OCT, cardiorespiratory exercise tests, exogenic factors like nutrition, smoking, lipid profile) with short-read whole-genome sequencing to elucidate the interplay of established PRS from the literature and exogenic risk factors with respect to HTx outcomes will be carried out. Besides that, a long-read whole-genome sequencing of 100 newly transplanted recipients and their corresponding donors and extend latest bioinformatics methods developed by the study to analyze long-read data will be performed. This will enable a comprehensive and integrated analysis of structural variants, polygenic risk, high-penetrance variant genotypes, immunogenetic (major and minor histocompatibility), and individual lifestyle risk factors in a unique donor-recipient cohort, elucidating the extent of within-cohort variability and cross-correlations between the considered potential risk factors and an exploratory analysis of the utility of genetic risk scores in light of the study results will be carried out.
Any member of the research team conducted screening for the selection of eligible patients. Nurses will be responsible for delivering the "Guide tips for the person with a transplanted heart", thus initiating an individualized education program. Education will be held at the time of admission in which the patient has passed the most critical post-operative. Educational tips guide contains all the information necessary for the patient to have a first contact on the habits that must change. Education lasts 10-30 minutes and is taught in daytime, in a calm environment and at the right time, favoring the presence of the caregiver. Later, education is reinforced on the doubts that arise both the patient and the primary caregiver. During the first days of admission to the unit of cardiology, socio-demographic data of the patient and primary caregiver by the research team will be collected. A few days before discharge, having left time between 7-8 days after delivery of educational advice guide, any member of the research team, who does not work in the cardiology unit, will provide the patient and the primary caregiver the satisfaction questionnaire where the perception of information and education received during the postoperative period in the inpatient cardiology unit and the appropriateness of the topics covered in the guide educational advice.
The ongoing success of transplantation is largely due to the development of drugs to stop the patient's body from rejecting the new organ. In addition to steroids, two main types of drug are used to suppress the immune system following heart transplantation: calcineurin inhibitors (Ciclosporin-A or Tacrolimus) and mycophenolate. However, different patients respond in different ways to these drugs, with the same dose leading to different levels of the drug in the blood. This varies due to genetic and other factors such as age, kidney function and the use of other drugs. Therefore, the levels of immunosuppressive drugs in the blood are routinely measured and the dose adjusted accordingly. However, some patients still experience episodes of rejection despite apparently acceptable levels. In this study, the investigators will measure levels of the drugs (in the blood, in a type of white blood cell called T-cells and in the heart muscle) and the effectiveness of the drugs on T-cells. The investigators will compare these levels with patient genetic factors and the amount of rejection measured on heart biopsies. This will enable us to better understand how the blood and tissue levels of these drugs change with genetic and other factors in order to optimise immunosuppressive therapy and further improve outcomes from heart transplantation.