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

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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 683

Contacts and Locations

• Study Contact: Name: Luciano Potena, MD; Phone Number: 0512143725; Email: scompenso.trapiantocuore@aosp.bo.it

Study Locations

• Italy
  • Bari
    • Bari, Bari, Italy, 70120
      • Not yet recruiting
      • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
      • Contact: Tomaso Bottio; Phone Number: +39335328307; Email: tomaso.bottio@uniba.it
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Luciano Potena, MD; Phone Number: 0512143725; Email: scompenso.trapiantocuore@aosp.bo.it
  • Milano
    • Milan, Milano, Italy, 20162
      • Recruiting
      • ASST Grande Ospedale Metropolitano Niguarda
      • Contact: Enrico Ammirati; Phone Number: 0264447791; Email: enrico.ammirati@ospedaleniguarda.it
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Recruiting
      • Azienda Ospedaliera dei Colli
      • Contact: Cristiano Amarelli; Phone Number: +393473311842; Email: cristiano.amarelli@ospedalideicolli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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. 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of patients with DSA among all the enrolled patients	prevalence	5 years
prevalence of fibrosis, edema and of altered T1 mapping values in patients with donor specific antibodies (DSA)	prevalence	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Collaborators: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari; ASST Grande Ospedale Metropolitano Niguarda; Azienda Ospedaliera dei Colli
• Investigators: Principal Investigator: Luciano Potena, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CARIBIAM; PNRR-MCNT2-2023-12377618 (Other Grant/Funding Number: Ministero della salute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No