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Heart Transplantation clinical trials

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NCT ID: NCT05268679 Completed - Clinical trials for Heart Transplantation

Covid-19 Vaccine Response in Heart Transplant Recipients

COVHEART
Start date: March 7, 2022
Phase:
Study type: Observational

Clinical studies indicate a decrease in vaccine efficacy in certain immunocompromised populations (kidney transplant recipients, patients undergoing chemotherapy). It was recently reported that only 18% to 49% of heart transplant recipients developed antibodies after 2 doses of BNT162b2 vaccine. Following the published results, it is currently recommended to use 3 doses in organ transplant recipients who have not contracted COVID-19 and 2 doses in those who have been infected. The effectiveness of this strategy is not yet sufficiently evaluated in heart transplant recipients. Moreover, the factors associated with the humoral and cellular response, the kinetics and durability of the humoral response, the occurrence of the cellular immune response and the tolerance of the vaccine are not well known in this population. To provide answers to these different questions, we set ourselves the objective of evaluating the humoral and cellular response to messenger RNA (mRNA) vaccines in heart transplant recipients followed at Bichat Hospital.

NCT ID: NCT04488094 Completed - Clinical trials for Liver Transplantation

Diagnostic Validity of [18F]FSPG PET for the Assessment of Acute Rejection After Heart or Liver Transplantation

Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

The a series of clinical studies of [18F]FSPG PET/CT showed that [18F]FSPG is safe and promising PET tracer for detecting inflammation with favorable biodistribution and pharmacokinetics in patients. By using [18F]FSPG, which targets system xCˉ, a key player in the active phase of inflammation, the goal of this phase 2 study is to evaluate diagnostic validity of [18F]FSPG PET/CT to detect allograft rejection after heart and liver allograft, where conventional imaging has limitations. Diagnostic efficacy of [18F]FSPG PET/CT will be determined in comparison with histologic evaluation of allograft biopsy. Other critical questions including whether quantitative measures of [18F]FSPG uptake is associated with the severity of rejection, inter-reader variability of [18F]FSPG PET/CT, and safety assessment will be also evaluated.

NCT ID: NCT04261998 Completed - Clinical trials for Heart Transplantation

Sevice-learning in Physiotherapy and Heart Transplantation and Acute Coronary Syndrome

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

A service-learning programme in physiotherapy students will be performed. 30 physiotherapy students will be randomly assigned to an intervention group (n=16) or to a control group (n=16). Intervention group will perform a service-learning program with real patients with heart transplantation, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics. The control group will have to perform a physiotherapy program without meeting real patients.

NCT ID: NCT04117152 Completed - Clinical trials for Heart Transplantation

Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation

TRAJ-CAV
Start date: January 1, 2004
Phase:
Study type: Observational [Patient Registry]

This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.

NCT ID: NCT03809676 Completed - Clinical trials for Periodontal Diseases

Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls

Start date: January 9, 2018
Phase:
Study type: Observational

Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data.

NCT ID: NCT03234205 Completed - Clinical trials for Heart Transplantation

Measurements of Myocardial Relaxation Time by MRI During Respiration

ARTEMIS
Start date: August 31, 2011
Phase: N/A
Study type: Interventional

Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable. This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts. The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients. The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.

NCT ID: NCT03105726 Completed - Heart Failure Clinical Trials

Medical Care Versus Ventricular Assist Device for the Management of End-stage Heart Failure (MEVADE)

MEVADE
Start date: November 2010
Phase: N/A
Study type: Observational

End-stage heart failure (ESHF) represents a major burden in terms of quality of life, mortality and costs. The current practice in France is to treat patients with ESHF by a combination of drugs and lifestyle interventions before proposing heart transplant (HT) if there is no contraindication. In the Heart and Diabetes Center of Bad Oyenhausen (BO) in Germany, patients presenting with ESHF are preferentially managed by ventricular assist device (VAD) therapy. The primary purpose of this study was to compare the outcomes of these two strategies in the management of ESHF and associated consumption of resources.

NCT ID: NCT03026634 Completed - Heart Failure Clinical Trials

Prevalence and Dynamic of Sleep-disordered Breathing in Patients Pre and Post Heart Transplantation

HTx-HDZ-SDB-1
Start date: January 1, 2017
Phase:
Study type: Observational [Patient Registry]

Sleep-disordered breathing is believed to appear at a high prevalence in end-stage heart failure patients and the presence of sleep-disordered breathing has been associated with increased mortality. This study is designed to investigate prevalence and dynamics of sleep-disordered breathing in end-stage heart failure patients pre and post heart transplantation.

NCT ID: NCT02864706 Completed - Clinical trials for Heart Transplantation

SCHEDULE Follow Up Visit 5-7 yr

CRAD001ANO05
Start date: January 18, 2016
Phase: Phase 4
Study type: Interventional

The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE (NCT01266148) main study.

NCT ID: NCT02602834 Completed - Clinical trials for Heart Transplantation

Imminently Effect of Interval Training With High Intensity (HIT) After Heart Transplantation

Start date: May 2015
Phase: N/A
Study type: Interventional

High intensity Interval training (HIT) has repeatedly been documented to have superior positive effects on oxygen uptake and general physical health compared to continuous moderate exercise in healthy individuals and patients with heart disease. Recently, the same effect has been shown in heart transplanted recipients. Which mechanisms that explains this difference is uncertain; the effect can be due to changes in the heart or changes in the peripheral tissue and muscles. To explore these mechanisms the investigators will in this study compare two different exercise modalities, and explore how different biomarkers change in blood, related to exercise.