Status:
ENROLLING_BY_INVITATION
National Multicenter Registry for Pediatric End-Stage Heart Failure in China
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Heart Failure
Children
Eligibility:
All Genders
Up to 18 years
Brief Summary
To establish a multicenter pediatric end-stage heart failure (ESHF) specialized disease data platform and promote its adoption across major children's medical centers nationwide. Based on this platfor...
Eligibility Criteria
Inclusion
- Patients who meet any of the following criteria despite receiving optimal guideline-directed medical therapy (GDMT):
- Severe and persistent heart failure symptoms \[New York Heart Association (NYHA) Class III (advanced) or IV\];
- Significant cardiac dysfunction, defined as:
- Left ventricular ejection fraction ≤30%
- Isolated right ventricular failure
- Non-operable severe valvular or congenital abnormalities
- Persistently elevated B-type natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) levels
- Severe diastolic dysfunction or left ventricular structural abnormalities (based on ESC definitions for heart failure with preserved ejection fraction \[HFpEF\] and heart failure with mildly reduced ejection fraction \[HFmrEF\]);
- Requirement of:
- High-dose intravenous diuretics (or combination diuretic therapy) for pulmonary/systemic congestion, OR
- Inotropic/vasoactive agents for low cardiac output, OR
- Management of malignant arrhythmias Resulting in \>1 unplanned hospital visits or admissions within the past 12 months;
- Severely impaired mobility due to cardiac causes with either:
- Inability to ambulate, OR
- 6-minute walk distance \<300 m, OR
- Peak oxygen consumption (PvO₂) \<12-14 mL/kg/min. -
Exclusion
- Concurrent life-limiting systemic disorders
- Structural cardiac lesions with indication for surgical/interventional correction -
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06927440
Start Date
December 1 2023
End Date
November 30 2026
Last Update
April 15 2025
Active Locations (1)
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1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 200000