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| ID | Type | Description | Link |
|---|---|---|---|
| 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 |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From date of transplantation up to 3 years post-transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Nianguo Dong, MD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
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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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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Donor left atrial appendages of surgical waste