Research on Precision Pharmaceutical Care for Heart Transplant Recipients

Heart Transplant Patients Clinical Trial

Official title:

Research on Precision Pharmaceutical Care for Heart Transplant Recipients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06326775
• Other study ID #: KY20240311-KS-02
• Status: Active, not recruiting
• Start date: March 12, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplant Patients

Locations

Country	Name	City	State
China	Pharmacy Department of Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University	Changhai Hospital, Shanghai Zhongshan Hospital, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)