Heart TransplantationCIRCA-HTxNCT07301788
Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation
An observational study of Heart Transplantation and End-stage Heart Failure, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Transplantation, End-stage Heart Failure, Circadian Rhythm
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients undergoing heart transplantation surgery at our hospital due to end-stage heart failure.
Who cannot join
- Exclude patients undergoing multi-organ combined transplantation, re-do heart transplantation, or those with a history of other organ transplantation.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
About this study
Official title: 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.
- Keywords
- Heart transplant, Donor heart procurement, Circadian Rhythm, Transplant outcomes, Survival analysis, Rejection, End-stage heart failure, Biomarkers, Multi-omics, Observational study, Prognostic factors
- Medical subject headings
- Rejection, Psychology
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of transplantation up to 3 years post-transplant.
Secondary outcomes (1)
Acute rejection rate
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).
Measured: From date of transplantation up to 3 years post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Oct 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nianguo Dong, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301788
- Sponsor's protocol ID
- 2023-0291
- Other IDs
- JCZRYB202500142, 2021YFA1101900, 82470423
- Acronym
- CIRCA-HTx
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Study on the Impact of Donor Heart Procurement Time on Recipient Prognosis After Heart Transplantation Based on Multi-Omics Analysis
- ClinicalTrials.gov ID
- NCT07301788
- Acronym / sponsor ID
- CIRCA-HTx / 2023-0291
- Keywords
- Heart transplant, Donor heart procurement, Circadian Rhythm, Transplant outcomes, Survival analysis, Rejection, End-stage heart failure, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients undergoing heart transplantation surgery at our hospital due to end-stage heart failure.
Key exclusion criteria (1 listed)
- Exclude patients undergoing multi-organ combined transplantation, re-do heart transplantation, or those with a history of other organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Acute rejection rate
Time frame: From date of transplantation up to 3 years post-transplant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nianguo Dong, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation and End-stage Heart Failure, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of transplantation up to 3 years post-transplant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.