Ireland
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Enrolling by invitation Observational

National Multicenter Registry for Pediatric End-Stage Heart Failure in China

NCT06927440 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2023-12-01
Last updated
2025-04-15

Condition(s) studied

Heart FailureChildren

Study 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 platform, conduct a national multicenter cohort study on specialized treatments for pediatric ESHF (including pharmacotherapy, ventricular assist devices, heart transplantation, etc.). This initiative will provide a foundational platform for advancing national clinical research on pediatric end-stage heart failure.

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: Concurrent life-limiting systemic disorders Structural cardiac lesions with indication for surgical/interventional correction -

Primary outcome measure(s)

  • Composite of cardiovascular death, heart transplantation, LVAD implantation or WHF hospitalization — From enrollment to the follow up at 1 year, 3 years, 5 years
    WHF hospitalization: The patient was hospitalized for worsening heart failure; LVAD: left ventricular assistant device

Trial sites (1)

FacilityCityRegionStatus
Shanghai Children's Medical Center Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06927440 on ClinicalTrials.gov ↗ ← All trials in China