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

Not yet recruiting

• Conditions: Heart Transplantation; Rejection Heart Transplant; HLA Antigens

• Registration Number: NCT06774365
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 683

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of fibrosis, edema and of altered T1 mapping values in patients with DSA	5 years	prevalence
prevalence of patients with DSA among all the enrolled patients	5 years	prevalence

Secondary Outcome Measures

Name	Time	Method
differences in dd-cfDNA in patients with and without DSA	5 years	differences in dd-cfDNA
differences in T-reg and dd-cfDNA in patients with and without abnormal CMR	5 years	differences in T-reg and dd-cfDNA
differences in T-reg subpopulation in patients with and without DSA	5 years	differences in T-reg subpopulation
change in DSA, biomarkers and CMR findings after vs before AMR treatment	5 years	change in DSA
MACE occurrence	5 years	MACE occurrence

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy