Cardiac imaging and biomarkers to help diagnose antibody mediated rejection after heart transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study prospectively enrolls heart transplant recipients who are clinically stable but have donor-specific antibodies detected during routine AMR screening. Researchers will collect CMR imaging data to assess inflammation and fibrosis, along with blood-based biomarkers such as dd-cfDNA and T-reg populations, without altering standard clinical care. The goal is to determine how common fibrosis, edema, and abnormal T1 values are in patients with DSA and how often DSA is present among enrolled participants. Data are collected at study entry and through routine follow-up as part of standard practice, with treating physicians blinded to study-specific assay results. Interventions are not specified and follow current clinical guidelines.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Bologna, Italy Recruiting
• ASST Grande Ospedale Metropolitano Niguarda
  Milan, Milano, Italy Recruiting
• Azienda Ospedaliera dei Colli
  Naples, Napoli, Italy Recruiting
• Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
  Bari, Bari, Italy Not yet recruiting

Study contacts

• Principal investigator: Luciano Potena, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Luciano Potena, MD
• Email: scompenso.trapiantocuore@aosp.bo.it
• Phone: 0512143725

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Extracellular Vesicles to Monitor Heart Transplant Rejection

  This study will test whether protein patterns in extracellular vesicles from heart transplant patients can signal acute rejection early.

  Recruiting Charite University, Berlin, Germany · Berlin, State of Berlin · NCT07673536

• Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant

  This project tests whether a blood test measuring donor-derived cell-free DNA can help monitor rejection in adults who have had a heart transplant.

  Recruiting Karolinska Institutet · Stockholm · NCT07531784

• Metabolic deterioration after heart transplant determines outcomes

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  Recruiting Heinrich-Heine University, Duesseldorf · Düsseldorf, North Rhine-Westphalia · NCT07372820

• Mapping fat-cell sizes around the coronary arteries to trace inflammation

  This project will test whether differences in fat-cell size next to the coronary arteries can show how inflammation spreads in people having a heart transplant for advanced heart failure.

  Recruiting Institute for Clinical and Experimental Medicine · Prague · NCT07360925

• Multimodal analysis of heart biopsy samples

  This project will take one extra small heart biopsy during a clinically needed procedure to test whether detailed molecular and immune analyses can find disease-specific signatures in adults with cardiomyopathies, myocarditis, cardiac amyloidosis, or after heart transplant.

  Recruiting University Hospital, Essen · Essen, North Rhine-Westphalia · NCT07359690

• Long-term health of children born to mothers who had a solid organ transplant

  This project will look for long-term heart, kidney, and immune system problems in people aged 16 and older who were born to mothers who had a kidney, liver, pancreas, heart, or lung transplant.

  Recruiting University Medical Center Groningen · Groningen, Provincie Groningen · NCT07291258

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.