NCT06774794 Precision Medicine in the Management of Heart Transplant Recipients
| NCT ID | NCT06774794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Heart Transplantation |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-09-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-09-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to demonstrate that a multiparametric approach, based on the integration of biomolecular, histological, imaging, and clinical information, along with the use of machine learning methods, can identify among heart transplant patients those at higher risk of rejection, infectious events, and chronic graft dysfunction. Patients have been and will be treated according to clinical practice, in accordance with the physician's judgment and the information provided in the Technical Data Sheet of each individual product used in concomitant therapies, if administered according to clinical practice. The diagnostic-therapeutic pathway of the patients will not be in any way influenced by the results of tissue tests performed for the purposes of the study
Eligibility 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.
Contact & Investigator
Luciano G Potena, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06774794 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06774794 currently recruiting?
Yes, NCT06774794 is actively recruiting participants. Contact the research team at scompenso.trapiantocuore@aosp.bo.it for enrollment information.
Where is the NCT06774794 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06774794 clinical trial?
NCT06774794 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Luciano G Potena, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 200 participants.