Actively Recruiting
CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-05-22
683
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
I
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
A
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying heart transplant recipients who are clinically stable but have donor specific antibodies (DSA) detected during routine monitoring. This observational study aims to assess inflammation and fibrosis in the heart using cardiac magnetic resonance imaging (CMR). The main focus is to understand how common fibrosis, swelling, and changes in T1 mapping values are among patients with DSA and the overall prevalence of DSA in the group studied. Participants will be enrolled when they have a DSA test as part of their regular heart transplant follow-up, which includes yearly screening for anti-HLA antibodies. Blood samples will be collected to measure donor-derived cell-free DNA (dd-cfDNA) and regulatory T cell (T-reg) populations. Treatments and procedures will follow standard medical guidelines and are not influenced by study results. Physicians caring for participants will not have access to study assay results to ensure unbiased clinical decisions. During the study, clinical information, medical history, and standard lab tests will be gathered at the start. The study will track the prevalence of heart tissue changes related to DSA over five years, as well as differences in biomarkers and imaging findings between patients with and without DSA. Researchers will also observe changes after antibody-mediated rejection treatment and monitor major adverse cardiac events (MACE). The total participation time extends up to five years with periodic assessments.
CONDITIONS
Brief Title
CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Heart transplant follow-up between 1 and 15 years
- Clinically stable and ambulatory
- Left ventricular ejection fraction (LVEF) above 40% as assessed by cardiac ultrasound within 3 months before enrollment
You will not qualify if you...
- Unplanned hospitalization for cardiovascular causes in the previous 3 months
- Biopsy-proven cellular rejection (2R or greater) or antibody mediated rejection (pAMR > 1) in the previous 3 months
- Any contraindication to cardiac magnetic resonance imaging (CMR)
- Known pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who undergo routine care are observed. Blood samples are collected to assay biomarkers and clinical data is recorded at baseline.
Yearly visits for antibody monitoring and biomarker sampling
Trial Site Locations
Total: 4 locations
1
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Bari, Italy, 70120
Not Yet Recruiting
2
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
3
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy, 20162
Actively Recruiting
4
Azienda Ospedaliera dei Colli
Naples, Napoli, Italy, 80131
Actively Recruiting
Research Team
L
Luciano Potena, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here