Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200000, China
NCT Number: NCT06927440
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.
Interested in participating?
Request InfoUp to 18 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200000, China
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 -
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
Shanghai Jiao Tong University School of Medicine
Other
Development and Implementation of a National Multicenter Registry for Pediatric End-Stage Heart Failure in China
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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