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

This trial does not accept healthy volunteers

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 population

Clinically stable adult heart transplanted patients will be consecutively enrolled during the routinely outpatient evaluation in the participating centers after IRB approval. Heart Failure and Transplant Unit of IRCCS AOUBO will be the project leader and coordinate the overall study. The investigators plan a one year period for the enrollment and eight months for the follow-up. Patients will be treated and followed according to the routinary clinical practice of each participating center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA)

prevalence

Time frame
5 years
2

prevalence of patients with DSA among all the enrolled patients

prevalence

Time frame
5 years

Secondary outcomes

1

differences in dd-cfDNA in patients with and without DSA

differences in dd-cfDNA

Time frame
5 years
2

differences in T-reg subpopulation in patients with and without DSA

differences in T-reg subpopulation

Time frame
5 years
3

differences in T-reg and dd-cfDNA in patients with and without abnormal CMR

differences in T-reg and dd-cfDNA

Time frame
5 years
4

change in DSA, biomarkers and CMR findings after vs before AMR treatment

change in DSA

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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