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Enrolling by Invitation

NCT Number: NCT06927440

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

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Primary outcomes

  1. Composite of cardiovascular death, heart transplantation, LVAD implantation or WHF hospitalization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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