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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Collaborator

Azienda Ospedaliera dei Colli

Collaborator

ASST Grande Ospedale Metropolitano Niguarda

Collaborator