Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

NCT07301788 | Completed

• 4 other identifiers: 2023-0291JCZRYB2025001422021YFA110190082470423
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the impact of donor heart procurement time based on circadian rhythm on the long-term outcomes of heart transplant recipients. The main question it aims to answer is: Does the time of day when a donor heart is procured-specifically during the circadian repression phase (00:00-12:00) versus the activation phase (12:00-00:00)-affect post-transplant survival and rejection rates in patients with end-stage heart failure? Patients undergoing heart transplantation at the study hospital will have leftover donor heart tissue and preservation fluid collected during surgery for multi-omics analysis. These participants will then be followed prospectively for up to three years to track survival and rejection outcomes.

Conditions

End-stage Heart Failure; Circadian Rhythm; Heart Transplantation

Keywords

Heart transplant; Donor heart procurement; Circadian Rhythm; Transplant outcomes; Survival analysis; Rejection; End-stage heart failure; Biomarkers; Multi-omics; Observational study; Prognostic factors

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Post-heart-transplant survival assessed from the date of transplantation until death from any cause, evaluated through regular follow-up visits over the study period.

  From date of transplantation up to 3 years post-transplant.

Secondary Outcomes (1)

• Acute rejection rate

  From date of transplantation up to 3 years post-transplant.

Eligibility Criteria

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

Study Population

This study will enroll adult patients diagnosed with end-stage heart failure who are scheduled to undergo heart transplantation at the study hospital. Participants must meet standard transplant eligibility criteria. Exclusion criteria are applied to minimize confounding factors, including previous organ transplants, re-transplants, and multi-organ transplant recipients, ensuring a more homogeneous study population focused on first-time, heart-only transplant cases.

You may qualify if:

• All patients undergoing heart transplantation surgery at our hospital due to end-stage heart failure.

You may not qualify if:

• Exclude patients undergoing multi-organ combined transplantation, re-do heart transplantation, or those with a history of other organ transplantation.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Donor left atrial appendages of surgical waste

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Nianguo Dong, MD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: October 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)