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

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how certain heart issues, specifically inflammation and scarring, can occur in people who have received a heart transplant. The researchers want to study patients who have specific antibodies (called DSA) that could indicate a risk for rejection of the transplanted heart. By using advanced imaging techniques, the study aims to identify the presence of damage in the heart muscle and to see how common these problems are among heart transplant recipients.

To participate in this trial, individuals need to be over 18 years old and have had their heart transplant between 1 to 15 years prior to joining the study. They should also be in stable health, meaning they are not facing any immediate heart problems, and their heart function is at least 40% as measured by a recent ultrasound. Participants will undergo imaging tests to help assess their heart condition, but they will not be required to stay in the hospital. This study is still in the planning stages and has not yet started recruiting participants.

Gender

ALL

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