NCT05775432

Brief Summary

Heart transplantation is the most effective treatment for end-stage heart failure, advanced cardiomyopathy, and complex congenital heart disease with severe heart failure or hypoxia. Several clinical studies have shown significant differences in the prognosis of heart transplantation patients with different etiologies, and post-transplantation complications are an important factor affecting patient survival, and there is still a lack of overall prognostic stratification and extensive clinical studies on risk factors after heart transplantation. Therefore, this study is intended to include patients who underwent heart transplantation for different etiologies of heart failure, collect clinical data and biological samples from patients, and use various techniques to deeply interpret the risk factors affecting the prognosis of heart transplantation patients and construct a prognostic prediction model to provide specific and individualized treatment ideas and theoretical basis for improving the survival rate of patients after heart transplantation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
202mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Apr 2023Dec 2042

First Submitted

Initial submission to the registry

February 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 23, 2023

Completed
19.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2042

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2042

Last Updated

July 12, 2024

Status Verified

March 1, 2024

Enrollment Period

19.7 years

First QC Date

February 14, 2023

Last Update Submit

July 10, 2024

Conditions

Heart Failure

Keywords

Heart transplantationHeart failurePrognosis

Outcome Measures

Primary Outcomes (1)

  • Change in the incidence of all-cause death

    Death from any cause in patients after heart transplantation, will be assessed from medical records.

    In-hospital (an average of 1 month), 1, 2, 3, 5, 10, 15 and 20 years after heart transplantation.

Secondary Outcomes (4)

  • Use of advanced life support (ALS)

    In-hospital (an average of 1 month)

  • Incidence of postoperative complications

    In-hospital (an average of 1 month)

  • ICU admission time

    In-hospital (an average of 1 month)

  • Change of cardiac function index

    In-hospital (an average of 1 month).

Study Arms (2)

Heart transplantation group

Patients with heart failure of different etiologies undergoing heart transplant.

Control group

Individuals whose hearts are donated.

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation are enrolled into heart transplantation group. Individuals whose hearts are donated are enrolled into control group.

You may qualify if:

  • Patients with end-stage heart failure presented to our hospital who are evaluated by clinicians and ethically approved for heart transplantation
  • Individuals whose hearts are donated

You may not qualify if:

  • Patients refuse to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, feces.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Guoliang Li

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

  • Yang Yan

    First Affiliated Hospital Xi'an Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

+8613759982523liguoliang_med@163.com

Yang Yan

CONTACT

+862985323865yangyan3@xjtu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2023

First Posted

March 20, 2023

Study Start

April 23, 2023

Primary Completion (Estimated)

December 31, 2042

Study Completion (Estimated)

December 31, 2042

Last Updated

July 12, 2024

Record last verified: 2024-03

Locations

CN(1)