National Multicenter Registry for Pediatric End-Stage Heart Failure in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Children. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development and Implementation of a National Multicenter Registry for Pediatric End-Stage Heart Failure in China
Overview
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.
Primary outcome measures
- 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]
Eligibility criteria
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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Children's Medical Center — Shanghai
Publications
- McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Up PMID 37622666
- Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of t PMID 35363499
Identifiers
NCT: NCT06927440 · 2023YFC2706201