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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA)
prevalence
prevalence of patients with DSA among all the enrolled patients
prevalence
Secondary outcomes
differences in dd-cfDNA in patients with and without DSA
differences in dd-cfDNA
differences in T-reg subpopulation in patients with and without DSA
differences in T-reg subpopulation
differences in T-reg and dd-cfDNA in patients with and without abnormal CMR
differences in T-reg and dd-cfDNA
change in DSA, biomarkers and CMR findings after vs before AMR treatment
change in DSA
Sponsors and contacts
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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