NCT06345521

Brief Summary

Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 28, 2024

Status Verified

March 1, 2024

Enrollment Period

2.5 years

First QC Date

March 28, 2024

Last Update Submit

May 23, 2024

Conditions

Keywords

Congenital Heart FailureRegistryEnd-stage Heart Failure

Outcome Measures

Primary Outcomes (1)

  • the recurrence rate of heart failure

    During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.

    6 months

Secondary Outcomes (3)

  • NT-proBNP level

    6 months

  • Incidence rate of drug adverse reactions

    6 months

  • Readmission rate for heart failure

    6 months

Study Arms (1)

End-Stage Heart Failure Group

Children with end-stage heart failure

Other: No intervention

Interventions

No intervention

End-Stage Heart Failure Group

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with end-stage heart failure

You may qualify if:

  • Patients younger than 14 years of age
  • refractory heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Shoujun Li

    Chinese Academy of Medical Sciences, Fuwai Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

January 1, 2022

Primary Completion

June 22, 2024

Study Completion

December 31, 2024

Last Updated

May 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations