MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
LEONE-HT
1 other identifier
observational
90
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
ExpectedJune 21, 2022
June 1, 2022
3.5 years
July 19, 2021
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Histology findings with transmission electron microscopy (TEM)
Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
14 days
Histology findings with optic microscopy (OM)
Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
14 days
Histology findings with immunohistochemistry (IHQ) techniques.
Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
14 days
Secondary Outcomes (10)
Microvascular function (pressure guidewire)
14 days
Microvascular function (pressure guidewire 2)
14 days
Microvascular function (cardiac magnetic resonance)
14 days
Increased water content (intracellular edema)
14 days
Myocardial fibrosis (cardiac magnetic resonance)
14 days
- +5 more secondary outcomes
Other Outcomes (1)
Adverse events
5 years
Study Arms (2)
Exposed: Positive anti-HLA antibodies
Heart transplant patients who have developed antiHLA antibodies after transplant
Non-exposed: Negative anti-HLA antibodies
Heart transplant patients without antiHLA antibodies with similar transplant date to its correspondent case.
Interventions
Ultrasound study to assess cardiac anatomy and function
MR to assess cardiac anatomy, function and tissue damage
Cathteterization to assess coronary anatomy. Intravascular ultrasound to obtained a detailed assessment of vessels anatomy. Guidewire pressure to assess microcirculation
Optic microscopy, immunofluorescence, transmission electron microscopy
Eligibility Criteria
The study population will be conformed of heart transplant patients who are under follow-up at 3 hospitals of the Autonomous Region of Madrid (Spain). All the three hospitals are national referral center for heart transplantation.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Publications (1)
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.
PMID: 36287047DERIVED
Biospecimen
Endomyocardial biopsy samples Blood samples (leukocytes)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Juan F Delgado, MD PhD
University Hospital 12 de Octubre
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Director of Heart Transplant programme MD, PhD
Study Record Dates
First Submitted
July 19, 2021
First Posted
January 11, 2022
Study Start
April 1, 2021
Primary Completion
September 30, 2024
Study Completion (Estimated)
September 30, 2029
Last Updated
June 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share