EchocardiogramCardiac magnetic resonanceCoronary angiographyEndomyocardial biopsy
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
Study 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
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. Non-exposed: Heart transplant procedure contemporary to the index case with negative anti-HLA antibodies.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Histology findings with transmission electron microscopy (TEM) — 14 days Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
Histology findings with optic microscopy (OM) — 14 days Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
Histology findings with immunohistochemistry (IHQ) techniques. — 14 days Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
Trial sites (3)
Facility
City
Region
Status
Hospital Universitario Puerta de Hierro Majadahonda
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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