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Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study

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 thi...

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Autores principales: Nuche, Jorge, de la Cruz Bertolo, Javier, Marco Clement, Irene, Sánchez, Violeta Sánchez, Sarnago Cebada, Fernando, Mancebo, Esther, Enguita, Ana Belén, Alonso-Riaño, Marina, Ruiz-Hurtado, Gema, López-Azor, Juan Carlos, Hernández-Pérez, Francisco José, Castrodeza, Javier, Sánchez González, Javier, Arribas Ynsaurriaga, Fernando, García-Cosío Carmena, María Dolores, Delgado, Juan F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9608829/
https://www.ncbi.nlm.nih.gov/pubmed/36287047
http://dx.doi.org/10.3390/mps5050075
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author Nuche, Jorge
de la Cruz Bertolo, Javier
Marco Clement, Irene
Sánchez, Violeta Sánchez
Sarnago Cebada, Fernando
Mancebo, Esther
Enguita, Ana Belén
Alonso-Riaño, Marina
Ruiz-Hurtado, Gema
López-Azor, Juan Carlos
Hernández-Pérez, Francisco José
Castrodeza, Javier
Sánchez González, Javier
Arribas Ynsaurriaga, Fernando
García-Cosío Carmena, María Dolores
Delgado, Juan F.
author_facet Nuche, Jorge
de la Cruz Bertolo, Javier
Marco Clement, Irene
Sánchez, Violeta Sánchez
Sarnago Cebada, Fernando
Mancebo, Esther
Enguita, Ana Belén
Alonso-Riaño, Marina
Ruiz-Hurtado, Gema
López-Azor, Juan Carlos
Hernández-Pérez, Francisco José
Castrodeza, Javier
Sánchez González, Javier
Arribas Ynsaurriaga, Fernando
García-Cosío Carmena, María Dolores
Delgado, Juan F.
author_sort Nuche, Jorge
collection PubMed
description 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.
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spelling pubmed-96088292022-10-28 Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study Nuche, Jorge de la Cruz Bertolo, Javier Marco Clement, Irene Sánchez, Violeta Sánchez Sarnago Cebada, Fernando Mancebo, Esther Enguita, Ana Belén Alonso-Riaño, Marina Ruiz-Hurtado, Gema López-Azor, Juan Carlos Hernández-Pérez, Francisco José Castrodeza, Javier Sánchez González, Javier Arribas Ynsaurriaga, Fernando García-Cosío Carmena, María Dolores Delgado, Juan F. Methods Protoc Protocol 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. MDPI 2022-09-25 /pmc/articles/PMC9608829/ /pubmed/36287047 http://dx.doi.org/10.3390/mps5050075 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Protocol
Nuche, Jorge
de la Cruz Bertolo, Javier
Marco Clement, Irene
Sánchez, Violeta Sánchez
Sarnago Cebada, Fernando
Mancebo, Esther
Enguita, Ana Belén
Alonso-Riaño, Marina
Ruiz-Hurtado, Gema
López-Azor, Juan Carlos
Hernández-Pérez, Francisco José
Castrodeza, Javier
Sánchez González, Javier
Arribas Ynsaurriaga, Fernando
García-Cosío Carmena, María Dolores
Delgado, Juan F.
Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study
title Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study
title_full Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study
title_fullStr Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study
title_full_unstemmed Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study
title_short Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study
title_sort rationale and protocol of the multimodality evaluation of antibody-mediated injury in heart transplantation (leone-ht) observational cross-sectional study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9608829/
https://www.ncbi.nlm.nih.gov/pubmed/36287047
http://dx.doi.org/10.3390/mps5050075
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