NCT06927440Enrolling by invitation
National Multicenter Registry for Pediatric End-Stage Heart Failure in China
Development and Implementation of a National Multicenter Registry for Pediatric End-Stage Heart Failure in China
Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 1 Dec 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Diseases
- Heart failure
- NCT number
- NCT06927440
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Dec 2023 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent life-limiting systemic disorders
Other illness
- Structural cardiac lesions with indication for surgical/interventional correction -
Who the study is looking for
- 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. -
Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Children's Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.