Status:
ACTIVE_NOT_RECRUITING
MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
Lead Sponsor:
Juan Francisco Delgado Jimenez
Collaborating Sponsors:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Conditions:
Transplant Failure
Heart Transplant Rejection
Eligibility:
All Genders
Brief Summary
Cross-sectional evaluation of antibody mediated injury in heart transplantation patients through a multimodal approach: electron microscopy, optic microscopy, immunohistochemistry techniques, transtho...
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) i...
Eligibility Criteria
Inclusion
- Exposed:
- 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.
- Non-exposed: Heart transplant procedure contemporary to the index case with negative anti-HLA antibodies.
Exclusion
- Recipient of a second HT
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05184426
Start Date
April 1 2021
End Date
September 30 2029
Last Update
June 21 2022
Active Locations (3)
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1
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
2
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
3
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041