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Tacrolimus and Personalized Therapy to Prevent Acute Rejection Episodes

NCT06338306 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2024-04-09

No results posted yet for this study

Summary

Heart transplant is the only effective treatment for people with advanced heart failure.

Post-transplant pharmacological therapies are of fundamental importance for the survival of individuals after surgery: although considerable progress has been made for combined immunosuppressive therapies, acute cellular and especially non-cellular rejection still represents a great challenge for doctors.

To verify the absence of the first signs of acute rejection, the analysis of numerous cardiac biopsies (EMB endomyocardial biopsies) is necessary during the first 12 months following the transplant.

Thanks to these scheduled checks, doctors are able to identify the first symptoms of possible chronic rejection and reduce its episodes.

Since the analysis of biopsies is also based on subjective interpretations, cases of erroneous conclusions are frequent.

The researchers of this study aim not only to analyze the biopsies according to the current best clinical practice, but also to evaluate how much anti-rejection drug is actually contained within them.

This is an analysis that is still little used for this type of transplant, which could provide very useful information to doctors.

The researchers will focus their attention on one drug in particular, tacrolimus, abbreviated to "TAC".

The amount of drug measured in biopsies will be compared with that measured in whole blood samples and in particular blood cells (peripheral blood mononuclear cells: PBMC).

The genetic characteristics of each person play an important role in the success of treatment with the drug. To best interpret the results, all participants will be asked to take a blood sample to identify some characteristics of their DNA that could influence the outcome of tacrolimus therapy.

Conditions

  • Heart Transplant Failure

Interventions

DRUG

Tacrolimus（FK506）

Prograf

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2022-06-30
Completion
2025-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06338306 on ClinicalTrials.gov