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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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9608829 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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