NCT04976517

Brief Summary

The aim of this study is to evaluat the impact of diabetes on cardiac function in patients with heart transplantation by multimodal imaging and analyse their prognosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

July 11, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

2.4 years

First QC Date

July 11, 2021

Last Update Submit

July 23, 2021

Conditions

Heart Transplant

Outcome Measures

Primary Outcomes (3)

  • all-cause mortality

    death from all causes

    up to 2023.12

  • acute rejection

    acute rejection required treatment

    up to 2023.12

  • readmission

    readmission from all causes

    up to 2023.12

Study Arms (3)

non-diabetes group

patients who underwent heart tranplantation without diabetes

pre-transplant diabetes group

patients who underwent heart tranplantation with diabetes before the transplantation

post transplant daibetes group

patients who underwent heart tranplantation without diabetes until after the transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who received a heart transplant after 2015

You may qualify if:

  • Adult patients who received a heart transplant after 2015

You may not qualify if:

  • The image quality is poor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Li Zhang, PhD

    Department of Ultrasound, Union Hospital, Wuhan, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zhang, PhD

CONTACT

18907131488zli429@hust.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD,FACC, FAHA, FASE

Study Record Dates

First Submitted

July 11, 2021

First Posted

July 26, 2021

Study Start

August 1, 2021

Primary Completion

December 31, 2023

Study Completion

March 31, 2024

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share