MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
NCT ID: NCT05184426
Last Updated: 2022-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
90 participants
OBSERVATIONAL
2021-04-01
2029-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Exposed: Positive anti-HLA antibodies
Heart transplant patients who have developed antiHLA antibodies after transplant
Echocardiogram
Ultrasound study to assess cardiac anatomy and function
Cardiac magnetic resonance
MR to assess cardiac anatomy, function and tissue damage
Coronary angiography
Cathteterization to assess coronary anatomy. Intravascular ultrasound to obtained a detailed assessment of vessels anatomy. Guidewire pressure to assess microcirculation
Endomyocardial biopsy
Optic microscopy, immunofluorescence, transmission electron microscopy
Non-exposed: Negative anti-HLA antibodies
Heart transplant patients without antiHLA antibodies with similar transplant date to its correspondent case.
Echocardiogram
Ultrasound study to assess cardiac anatomy and function
Cardiac magnetic resonance
MR to assess cardiac anatomy, function and tissue damage
Coronary angiography
Cathteterization to assess coronary anatomy. Intravascular ultrasound to obtained a detailed assessment of vessels anatomy. Guidewire pressure to assess microcirculation
Endomyocardial biopsy
Optic microscopy, immunofluorescence, transmission electron microscopy
Interventions
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Echocardiogram
Ultrasound study to assess cardiac anatomy and function
Cardiac magnetic resonance
MR to assess cardiac anatomy, function and tissue damage
Coronary angiography
Cathteterization to assess coronary anatomy. Intravascular ultrasound to obtained a detailed assessment of vessels anatomy. Guidewire pressure to assess microcirculation
Endomyocardial biopsy
Optic microscopy, immunofluorescence, transmission electron microscopy
Eligibility Criteria
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Inclusion Criteria
* Heart transplant recipients
* "De novo" antiHLA detection (after heart transplant):
* Mean fluorescence intensity (MFI)) \> 2000 for donor-specific antibodies
* Standard fluorescence intensity (SFI) \> 150 000 for non-donor specific antibodies
* Detailed immunological history:
* Determination of anti-HLA antibodies before heart transplant.
* Serial determination of anti-HLA antibodies during heart transplantation follow-up
* Known HLA typing of the donor.
2. Non-exposed: Heart transplant procedure contemporary to the index case with negative anti-HLA antibodies.
Exclusion Criteria
* Multiple organ transplantation
* Unknown immunological history
* Recipients sensitized with anti-HLA antibodies against donor's HLA before the transplant
* CMR contrast will not be administered in patients with glomerular filtration rate \< 30 ml/kg/1.73m2
* Patients with implanted cardiac devices or any other magnetic resonance non-compatible metallic prosthetic material will not undergo CMR.
ALL
No
Sponsors
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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
OTHER
Juan Francisco Delgado Jimenez
OTHER
Responsible Party
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Juan Francisco Delgado Jimenez
Medical Director of Heart Transplant programme MD, PhD
Principal Investigators
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Juan F Delgado, MD PhD
Role: STUDY_CHAIR
University Hospital 12 de Octubre
Locations
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Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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References
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Nuche J, de la Cruz Bertolo J, Marco Clement I, Sanchez VS, Sarnago Cebada F, Mancebo E, Enguita AB, Alonso-Riano M, Ruiz-Hurtado G, Lopez-Azor JC, Hernandez-Perez FJ, Castrodeza J, Sanchez Gonzalez J, Arribas Ynsaurriaga F, Garcia-Cosio Carmena MD, Delgado JF. Rationale and Protocol of the Multimodality Evaluation of Antibody-Mediated Injury in Heart Transplantation (LEONE-HT) Observational Cross-Sectional Study. Methods Protoc. 2022 Sep 25;5(5):75. doi: 10.3390/mps5050075.
Other Identifiers
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LEONE-HT
Identifier Type: -
Identifier Source: org_study_id
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