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

Recruitingn/aAges 18 Years - anyAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06774365 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

4 sites
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera dei Colli
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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