Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure

Recruiting

• Conditions: End-stage Heart Failure; Congenital; Heart Failure
• Interventions: Other: No intervention

• Registration Number: NCT06345521
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-06-22
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
End-Stage Heart Failure Group	No intervention	Children with end-stage heart failure

Primary Outcome Measures

Name	Time	Method
the recurrence rate of heart failure	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, China