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

NCT06774365 | Recruiting

• 2 other identifiers: CARIBIAMPNRR-MCNT2-2023-12377618
• Study Type: observational
• Target: 683
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Heart Transplantation; Rejection Heart Transplant; HLA Antigens

Outcome Measures

Primary Outcomes (2)

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

  prevalence

  5 years

• prevalence of patients with DSA among all the enrolled patients

  prevalence

  5 years

Secondary Outcomes (5)

• differences in dd-cfDNA in patients with and without DSA

  5 years

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

  5 years

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

  5 years

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

  5 years

• MACE occurrence

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Azienda Ospedaliera dei Colli: collaborator
• ASST Grande Ospedale Metropolitano Niguarda: collaborator

Study Sites (4)

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, Bari, 70120, Italy

NOT YET RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, 20162, Italy

RECRUITING

Azienda Ospedaliera dei Colli

Naples, Napoli, 80131, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood samples, from which cfDNA will be extracted.

Study Officials

• Luciano Potena, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Potena, MD

CONTACT

0512143725; scompenso.trapiantocuore@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: November 7, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

IT (4)