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

Development and Implementation of a National Multicenter Registry for Pediatric End-Stage Heart Failure in China

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06927440

Enrollment

1000

Registered

2025-04-15

Start date

2023-12-01

Completion date

2026-11-30

Last updated

2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Heart Failure

Keywords

end-stage heart failure, pediatric

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results