Using Tacrolimus to Prevent Heart Transplant Rejection
Therapeutic Drug Monitoring of Tacrolimus Personalized Therapy in Heart Transplantation: New Strategies
This study is testing if using Tacrolimus can help heart transplant patients avoid rejection by personalizing their treatment based on regular checks of their heart tissue.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06338306 on ClinicalTrials.gov |
What this trial studies
This study focuses on heart transplant recipients and aims to improve the management of acute rejection episodes through personalized therapy with Tacrolimus. It involves the analysis of endomyocardial biopsies (EMB) to monitor for signs of rejection during the first year post-transplant. The researchers will evaluate biopsy results to enhance diagnostic accuracy and reduce the risk of false positives and negatives, which can lead to inappropriate treatment decisions. The goal is to guide clinicians in timely interventions to prevent chronic rejection and improve long-term graft survival.
Who should consider this trial
Good fit: Ideal candidates for this study are de novo heart transplant recipients who are starting their post-transplant care.
Not a fit: Patients under 18 years of age or those with intolerances to Tacrolimus or glucose, as well as individuals with diabetes mellitus, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute rejection episodes in heart transplant patients, leading to better long-term outcomes.
How similar studies have performed: Other studies have shown promise in using personalized immunosuppressive therapies to manage transplant rejection, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: de novo heart transplant recipient Exclusion Criteria: * Age \< 18 years * Intolerance to TAC or to some excipient * Intolerance to glucose * diabetes mellitus
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandra Ferrari
- Email: alessandra.ferrari@smatteo.pv.it
- Phone: +390382503689
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.