Clinical trial NCT06774365: CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
Official title: CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Transplantation
Rejection Heart Transplant
HLA Antigens
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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. We 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.

Brief summary: The goal of thisobservational 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

Detailed description: This is a multicentric prospective study with experimental sample collection. Therapy and procedures will be performed according to clinical practice and current guidelines. Caring physicians will be blinded to the results of study specific assays, which will not be used to change standard cynical decision making. Patients will be enrolled in the study at the time of the DSA assay performed in the context of standard surveillance (yearly monitoring for anti-HLA antibodies is recommended by current guidelines and is part of routine clinical practice). At study entry patients will receive blood sampling to assay dd-cfDNA (centralized laboratory) and T-reg populations (local laboratory). Clinical characteristics, medical history, and results of standard laboratory tests will be collected at baseline.

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA
timeFrame: 5 years
measure: prevalence of patients with DSA among all the enrolled patients
timeFrame: 5 years
Secondary outcomes:
measure: differences in dd-cfDNA in patients with and without DSA
timeFrame: 5 years
measure: differences in T-reg subpopulation in patients with and without DSA
timeFrame: 5 years
measure: differences in T-reg and dd-cfDNA in patients with and without abnormal CMR
timeFrame: 5 years
measure: change in DSA, biomarkers and CMR findings after vs before AMR treatment
timeFrame: 5 years
measure: MACE occurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luciano Potena, MD
role: PRINCIPAL_INVESTIGATOR
References: