NCT05184426

MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Juan Francisco Delgado Jimenez · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Transplant Failure
• Heart Transplant Rejection
• Antibody-mediated Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiogram	Ultrasound study to assess cardiac anatomy and function
DIAGNOSTIC_TEST	Cardiac magnetic resonance	MR to assess cardiac anatomy, function and tissue damage
DIAGNOSTIC_TEST	Coronary angiography	Cathteterization to assess coronary anatomy. Intravascular ultrasound to obtained a detailed assessment of vessels anatomy. Guidewire pressure to assess microcirculation
DIAGNOSTIC_TEST	Endomyocardial biopsy	Optic microscopy, immunofluorescence, transmission electron microscopy

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-09-30
• Completion: 2029-09-30
• First posted: 2022-01-11
• Last updated: 2022-06-21

Locations

3 sites across 1 country: Spain