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Cross-sectional evaluation of antibody mediated injury in heart transplantation patients through a multimodal approach: electron microscopy, optic microscopy, immunohistochemistry techniques, transthoracic echocardiography, cardiac magnetic resonance, pressure guide wire, intravascular ultrasound
Heart transplant survival has barely improved in the last decades and unsatisfactory for a large proportion of heart transplant recipients. The development of leukocyte antigen antibodies (anti-HLA) in the post-transplant patient is associated to the main causes of graft dysfunction. The mechanisms of this damage are unclear and there's no effective treatment. The investigators aim is to identify early markers of graft injury through a complete morphological and functional evaluation with histological analysis, immunological assays, advanced imaging techniques and invasive evaluation of coronary vasculature in patients with anti-HLA compared to matching controls. The investigators propose a cross-sectional study within a large heart transplant cohort. This is a multicentric observational multimodal study. The investigators aim is to establish early characteristics of antibody mediated damage and set the bases for future studies looking for new treatment targets.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Start Date
April 1, 2021
Primary Completion Date
September 30, 2024
Completion Date
September 30, 2029
Last Updated
June 21, 2022
90
ESTIMATED participants
Echocardiogram
DIAGNOSTIC_TEST
Cardiac magnetic resonance
DIAGNOSTIC_TEST
Coronary angiography
DIAGNOSTIC_TEST
Endomyocardial biopsy
DIAGNOSTIC_TEST
Lead Sponsor
Juan Francisco Delgado Jimenez
Collaborators
NCT05732779
NCT06753916
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT05525507