Using advanced methods to manage heart transplant patients
Precision Medicine in the Management of the Heart Transplant Patient: Advanced Molecular and Imaging Approaches
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06774794
This study is testing a new way to help doctors better manage heart transplant patients by using advanced data methods to spot those at higher risk for rejection and other complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06774794 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to utilize a multiparametric approach that integrates biomolecular, histological, imaging, and clinical data to identify heart transplant recipients at higher risk for rejection, infections, and chronic graft dysfunction. Patients will undergo standard clinical practices, including myocardial biopsies, while additional non-invasive investigations and analyses will be performed to correlate findings with histopathological results. The study will also explore the use of machine learning techniques to develop predictive algorithms for rejection risk based on these comprehensive data sets.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have received an orthotopic heart transplant and require a myocardial biopsy for clinical reasons.
Not a fit: Patients with severe post-operative complications that may limit their short-term survival are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved monitoring and management of heart transplant patients, potentially reducing the risk of rejection and other complications.
How similar studies have performed: While the integration of various data types and machine learning in transplant management is an emerging field, this specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Have received an orthotopic heart transplant * Clinical indication for performing a myocardial biopsy (either as part of standard monitoring or for suspected rejection) * Obtaining informed consent Exclusion Criteria: * Severe complications in the post-operative phase that may limit the patient's short-term survival.
Where this trial is running
Bologna
- Luciano — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Luciano G Potena, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Luciano Potena, MD
- Email: scompenso.trapiantocuore@aosp.bo.it
- Phone: 0512143725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Transplantation