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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Transplant Patients

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Pharmacy Department of Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing allogeneic orthotopic heart transplantation under cardiopulmonary bypass (CPB) for the first time.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steady state whole blood trough concentration of tacrolimus	Steady state whole blood trough concentration is a commonly used therapeutic drug monitoring indicator for tacrolimus.	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)

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Collaborators: Changhai Hospital; Shanghai Zhongshan Hospital; Wuhan Union Hospital, China
• Investigators: Study Director: Junrong Zhu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KY20240311-KS-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No