Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation (CIRCA-HTx)

December 11, 2025 updated by: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute rejection rate
Time Frame: 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).
From date of transplantation up to 3 years post-transplant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Nianguo Dong, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0291
  • JCZRYB202500142 (Other Grant/Funding Number: Hubei Provincial Natural Science Foundation Projects)
  • 2021YFA1101900 (Other Grant/Funding Number: National Key Research and Development Program)
  • 82470423 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared publicly. All data collected will be used solely by the research team for the analysis purposes outlined in this protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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