RecruitingNCT06774365

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

683 participants

Start Date

Nov 7, 2024

Study Type

OBSERVATIONAL

Conditions

Heart Transplantation Rejection Heart Transplant HLA Antigens

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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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