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

RECRUITINGSponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna
Actively Recruiting
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Started2024-11-07
Est. completion2029-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06774365

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

HLA AntigensHeart DiseaseHeart TransplantationRejection Heart Transplant

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