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Clinical Trials in Italy / NCT06774365
Recruiting Observational

CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation

NCT06774365 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2024-11-07
Last updated
2026-05-22

Condition(s) studied

Heart TransplantationRejection Heart TransplantHLA Antigens

Study summary

The goal of this observational study is to systematically assess the presence and distribution of CMR-defined inflammation and fibrosis in clinically stable HT recipients with DSA detected during active screening for AMR surveillance. The main outcome is to study the prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA and the prevalence of patients with DSA among all the enrolled patients

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \> 18 years * Post heart transplantation follow-up between 1 and 15 y * Ambulatory clinical stable * Left ventricular ejection fraction (LVEF) \> 40% (as assessed by complete cardiac ultrasound within 3 months before the enrolment) Exclusion Criteria: * Unplanned hospitalization for cardiovascular causes in the previous three months * Biopsy-proven cellular (2R or greater) or AMR (pAMR\> 1 ) in the previous 3 months * Any contraindication to CMR * Known pregnancy

Primary outcome measure(s)

  • prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA) — 5 years
    prevalence
  • prevalence of patients with DSA among all the enrolled patients — 5 years
    prevalence

Trial sites (4)

FacilityCityRegionStatus
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari Bari Bari Not Yet Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan Milano Recruiting
Azienda Ospedaliera dei Colli Naples Napoli Recruiting

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Other trials for the same condition

Non-ischemic Preservation of the Donor Heart in Heart Transplantation Active, not recruiting
Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients Starting soon
Precision Medicine in the Management of Heart Transplant Recipients Recruiting
Electronic Register on Advanced Heart Failure and Transplantation di Cuore Recruiting
Official registry record

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.

View NCT06774365 on ClinicalTrials.gov ↗ ← All trials in Italy