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Donor Circadian Rhythm and Its Correlation With Prognosis After Heart Transplantation

NCT ID: NCT07301788

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplantation End-stage Heart Failure Circadian Rhythm

Keywords

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Heart transplant Donor heart procurement Circadian Rhythm Transplant outcomes Survival analysis Rejection End-stage heart failure Biomarkers Multi-omics Observational study Prognostic factors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nianguo Dong, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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JCZRYB202500142

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021YFA1101900

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82470423

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-0291

Identifier Type: -

Identifier Source: org_study_id