NCT06039553招募中不适用
A Comprehensive Research of Pediatric Heart Failure -- A Self-control Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- the recurrence rate of heart failure
研究概览
简要总结
The goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.
The main questions it aims to answer are:
- Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF.
- Can the complications caused by the PAB therapy be clinically acceptable? Participants underwent PAB therapy will be required to underwent echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare the LV function 6 months after PAB suergey and the preoperative ones to see if there is improvement.
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients younger than 14 years of age
- •congenital heart failure (LVEF<55%, or LVFS<25%)
排除标准
- •single ventricle
- •congenital heart disease without anatomical correction
- •Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
- •Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U)
- •Patients with severe liver and kidney failure
- •Patients who are allergic to related medications
- •Patients with symptomatic hypotension who cannot tolerate related drugs
- •Refuse to sign the informed consent or refuse to participate in this experiment
结局指标
主要结局
the recurrence rate of heart failure
时间窗: after 6 months of PAB surgery
During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence.
次要结局
- Incidence rate of drug adverse reactions(after 6 months of PAB surgery)
- NT-proBNP level(after 6 months of PAB surgery)
- Readmission rate for heart failure(after 6 months of PAB surgery)
研究者
Shoujun Li
Director of Congenital Heart Surgery Center
China National Center for Cardiovascular Diseases
研究点 (1)
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