NCT05184426View on ClinicalTrials.gov

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

Active, not recruitingOBSERVATIONAL
Enrollment

90

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2029

Conditions
Transplant FailureHeart Transplant RejectionAntibody-mediated Rejection
Interventions
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

Trial Locations (3)

28007

Hospital General Universitario Gregorio Marañon, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

All Listed Sponsors
collaborator

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

lead

Juan Francisco Delgado Jimenez

OTHER