2026-07-22T05:26:16Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/166432024-09-27T08:10:51Zcom_20.500.12105_19604com_20.500.12105_2051col_20.500.12105_19605

00925njm 22002777a 4500 dc Nuche, Jorge author de la Cruz Bertolo, Javier author Marco Clement, Irene author Sánchez, Violeta Sánchez author Sarnago Cebada, Fernando author Mancebo, Esther author Enguita, Ana Belén author Alonso-Riaño, Marina author Ruiz-Hurtado, Gema author López-Azor, Juan Carlos author Hernández-Pérez, Francisco José author Castrodeza, Javier author Sánchez González, Javier author Arribas Ynsaurriaga, Fernando author García-Cosío Carmena, María Dolores author Delgado, Juan F author 2022-09-25 INTRODUCTION Heart transplant (HT) survival has barely improved in the last decades, which is unsatisfactory for many HT recipients. The development of anti-human leukocyte antigen (anti-HLA) antibodies in HT patients is associated with a cardiac allograft dysfunction. The mechanisms leading to this damage are unclear. The Multimodality Evaluation Of Antibody-Mediated Injury In Heart Transplantation (LEONE-HT) study aimed to thoroughly describe the damage inflicted on the myocardium by anti-HLA antibodies. METHODS AND ANALYSIS The LEONE-HT study is a cohort study with a cross-sectional approach in which HT patients with positive anti-HLA antibodies are compared with coetaneous HT patients with negative anti-HLA antibodies. All patients will undergo a state-of-the-art multimodal assessment, including imaging techniques, coronary anatomy and physiology evaluations and histological and immunological analyses. The individual and combined primary outcomes of structural graft injuries and longitudinal secondary outcomes are to be compared between the exposed and non-exposed groups with univariate and multivariable descriptive analyses. ETHICS AND DISSEMINATION The LEONE-HT study is carried out in accordance with the principles set out in the Declaration of Helsinki and the International Conference on Harmonization guidelines for good clinical practice and following national laws and regulations. The study design, objectives and participant centers have been communicated to clinicaltrials.gov (NCT05184426). The LEONE-HT study counts on the support of patient associations to disseminate the objectives and results of the research. This study was funded by the Spanish Ministry of Science and Innovation and the Spanish Society of Cardiology. Methods Protoc . 2022 Sep 25;5(5):75. 10.3390/mps5050075 2409-9279 Methods and protocols 36287047 http://hdl.handle.net/20.500.12105/16643 Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study.