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Enrolling by invitationNCT06927440Updated Apr 15, 2025

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

An observational study in Heart Failure and Children, sponsored by Shanghai Jiao Tong University School of Medicine. Enrolling by invitation at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-15.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
Up to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Heart Failure
  • Children

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Keywords

  • end-stage heart failure
  • pediatric
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In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 370 studies on the registry; 107 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Concurrent life-limiting systemic disorders

Structural cardiac lesions with indication for surgical/interventional correction -

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

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What researchers measure

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

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

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Study locations

1 site
  • Shanghai Children's Medical Center
    Shanghai, Shanghai Municipality 200000, China
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References and documents

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 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. PubMed 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 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. PubMed 35363499 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2023 (actual). Primary completion is estimated for Nov 2026, 35 months after the start.

Of 665 non-industry observational studies under Heart Failure, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 89. This study's planned 35 months is below that.

Counting every sponsor, half of 825 studies reached it within 40 months; a quarter within 21 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
Apr 15, 2025
StartActual
Dec 1, 2023
Primary completionEst.
Nov 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Apr 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06927440
Collaborators
Ministry of Science and Technology of the People´s Republic of China
Responsible party
Lijun Fu (Director of the Department of Cardiology, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Apr 15, 2025
Start date
Dec 1, 2023
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Apr 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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