Development and Implementation of a National Multicenter Registry for Pediatric End-Stage Heart Failure in China
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Composite of cardiovascular death, heart transplantation, LVAD implantation or WHF hospitalization
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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. -
排除标准
- •Concurrent life-limiting systemic disorders
- •Structural cardiac lesions with indication for surgical/interventional correction -
结局指标
主要结局
Composite of cardiovascular death, heart transplantation, LVAD implantation or WHF hospitalization
时间窗: 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
次要结局
未报告次要终点
研究者
Lijun Fu
Director of the Department of Cardiology, Shanghai Children's Medical Center
Shanghai Jiao Tong University School of Medicine