The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry

March 28, 2024 updated by: China National Center for Cardiovascular Diseases

A Comprehensive Research of Pediatric Heart Failure--The Follow-up System of Pediatric Heart Failure and the Establishment of End-stage Heart Failure Registry

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children with end-stage heart failure

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
End-Stage Heart Failure Group
Children with end-stage heart failure
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the recurrence rate of heart failure
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-proBNP level
Time Frame: 6 months
The trend in NT-proBNP levels.
6 months
Incidence rate of drug adverse reactions
Time Frame: 6 months
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
6 months
Readmission rate for heart failure
Time Frame: 6 months
During follow-up visits, readmission for heart failure will be recorded.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Collaborators

Peking University First Hospital
Beijing Children's Hospital

Investigators

  • Study Chair: Shoujun Li, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

June 22, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-1-4032-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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