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

NCT06927440 | Enrolling By Invitation DMC

• 1 other identifier: 2023YFC2706201
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Children

Keywords

end-stage heart failure; pediatric

Outcome Measures

Primary Outcomes (1)

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

  WHF hospitalization: The patient was hospitalized for worsening heart failure; LVAD: left ventricular assistant device

  From enrollment to the follow up at 1 year, 3 years, 5 years

Study Arms (1)

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

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with end-stage heart failure (ESHF) receiving care at multiple Chinese tertiary referral centers

You may qualify if:

• 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
• minute walk distance \<300 m, OR

You may not qualify if:

• Concurrent life-limiting systemic disorders
• Structural cardiac lesions with indication for surgical/interventional correction -

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (2)

• 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 Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

  PMID: 37622666 BACKGROUND

• 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 the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiology, Shanghai Children's Medical Center

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: December 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)