Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

A Mechanistic Study on the Impact of Donor Heart Procurement Time on Recipient Prognosis After Heart Transplantation Based on Multi-Omics Analysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07301788

Acronym

CIRCA-HTx

Enrollment

200

Registered

2025-12-24

Start date

2023-10-01

Completion date

2025-12-01

Last updated

2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm, End-stage Heart Failure, 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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	From date of transplantation up to 3 years post-transplant.	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.

Secondary

Measure	Time frame	Description
Acute rejection rate	From date of transplantation up to 3 years post-transplant.	Incidence of acute cellular rejection following heart transplantation, diagnosed based on endomyocardial biopsy per International Society of Heart and Lung Transplantation (ISHLT) grading criteria (grade 2R or higher).

Countries

China

Outcome results