Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study.
Jorge NucheJavier de la Cruz BertoloIrene Marco ClementVioleta Sánchez SánchezFernando Sarnago CebadaEsther ManceboAna Belén EnguitaMarina Alonso-RiañoLuis M RuilopeJuan Carlos López-Azor GarcíaFrancisco José Hernández-PérezJavier CastrodezaJavier Sánchez GonzálezFernando Arribas YnsaurriagaMaría Dolores García-Cosío CarmenaJuan Francisco DelgadoPublished in: Methods and protocols (2022)
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.