Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06326775

Research on Precision Pharmaceutical Care for Heart Transplant Recipients

Establishing personalized dose prediction and related adverse drug reaction prediction models for immunosuppressive drugs after heart transplantation using multiple methods to construct a precise pharmaceutical service system for heart transplant patients has important research value and clinical significance in improving the safety and effectiveness of medication for patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Heart Transplant Patients

Sex eligibility

All sexes

Study type

Observational

Primary location

Pharmacy Department of Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

In recent years, model-guided precision medication has become synonymous with modern individualized drug therapy methods. Heart transplantation (HT) is the preferred treatment for patients with end-stage heart failure, as it not only improves the quality of life but also extends the patient's lifespan. However, the host's immune response to the allograft after transplantation has always been one of the main factors affecting the short-term and long-term survival rates after heart transplantation. Recipients need to take immunosuppressants for a long time to improve the long-term survival rate of the graft and the recipient. However, there is a significant individual difference in the clinical application of these drugs. Establishing a risk prediction assessment model for drug administration and an evaluation system for pharmacodynamics and adverse events is an urgent clinical issue to be resolved. For example, tacrolimus (TAC) is a macrolide calcineurin inhibitor with strong immunosuppressive properties. More than 93% of heart transplant recipients use TAC to prevent transplant rejection, which is the cornerstone of the triple immunosuppressive regimen. Studies have shown that acute rejection, infection, acute kidney injury, and other complications usually occur in the early stage after heart transplantation and are significantly related to TAC blood concentration levels. Therefore, accurately estimating the individualized dosage of immunosuppressants after transplantation and accurately predicting the risk of various adverse events such as rejection, infection, and acute kidney injury in heart transplant patients after taking immunosuppressants, constructing a precise pharmaceutical service system for heart transplant patients, can improve the safety and effectiveness of medication for heart transplant patients, and has important clinical value.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients after heart transplantation

Exclusion criteria

  • Graft failure or death after surgery
  • Patients who have received two or more organ transplants
  • Patients with incomplete clinical data

Treatment and study plan

Primary outcomes

  1. Steady state whole blood trough concentration of tacrolimus

    Time frame: Three days after the first dose or adjustment, blood samples were taken 2 hours before the next dose to measure the steady state whole blood trough concentration of tacrolimus(From admission to discharge, assessed up to 2 months)

    Steady state whole blood trough concentration is a commonly used therapeutic drug monitoring indicator for tacrolimus.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Collaborators

  • Changhai Hospital
  • Shanghai Zhongshan Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.