Research on Precision Pharmaceutical Care for Heart Transplant Recipients

NCT06326775 | Active Not Recruiting

• 1 other identifier: KY20240311-KS-02
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Transplant Patients

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients after heart transplantation

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Changhai Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Pharmacy Department of Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Study Officials

• Junrong Zhu

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Pharmacy Department

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 22, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)