Not Yet RecruitingNot Applicable

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

Italy683 participantsStarted 2025-01

Plain-language summary

The goal of thisobservational 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA

Timeframe: 5 years

prevalence of patients with DSA among all the enrolled patients

Timeframe: 5 years

Trial details

NCT IDNCT06774365

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12

Contact for this trial

Luciano Potena, MD

0512143725 scompenso.trapiantocuore@aosp.bo.it

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