NCT05184426Active, not recruiting
MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
Source: ClinicalTrials.gov · Last updated 21 Jun 2022
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 19 Jul 2021
- Start date
- 1 Apr 2021
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Juan Francisco Delgado Jimenez
- NCT number
- NCT05184426
What you commit to
- Study type: Observational
- Planned participants: 90
- From 1 Apr 2021 to the primary completion date, 30 Sept 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Multiple organ transplantation
- Recipients sensitized with anti-HLA antibodies against donor's HLA before the transplant
Other illness
- Patients with implanted cardiac devices or any other magnetic resonance non-compatible metallic prosthetic material will not undergo CMR.
Other
- Recipient of a second HT
- Unknown immunological history
- CMR contrast will not be administered in patients with glomerular filtration rate \< 30 ml/kg/1.73m2
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.