CompletedNot Applicable

Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

China200 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

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

Trial details

NCT IDNCT07301788

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Heart Transplantation trials