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

Shanghai Jiao Tong University School of Medicine

Status: Invitation-only

Conditions: Children; Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT06927440

2023YFC2706201

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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 -

Trial design

1,000 participants in 1 patient group

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

Description:

A prospective multicenter cohort study on pediatric end-stage heart failure (ESHF) in China focusing on multicenter, multidimensional comprehensive analysis of demographic characteristics, risk factors, treatment efficacy, etiologies, prognoses, complications