NCT07692256招募中2 期
the Clinical Outcome of Empagliflozin in Pediatric Heart Failure Patients
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- serum Brain Natriuretic Peptide (BNP) in pg/mL
研究概览
简要总结
the study to investigate the efficacy of empagiflozin in pediatric heart failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Pediatrics (aged 1months-18 years)
- •Confirmed HF diagnosis:
- •HF will be defined by reduced ventricular systolic function (left ventricular ejection fraction by echocardiography) or impaired ventricular filling (pulmonary capillary wedge pressure > 18 mmHg measured directly and/or the ratio of early diastolic mitral inflow velocity(E) to early diastolic mitral annular velocity (e')( E/e'>14 by echocardiography) with clinical features of congestion and/or low cardiac output.
- •Class III or IV of ROSS classification or BNP level more than 300 pg/mL
排除标准
- •• Pediatric with chronic kidney failure
- •Avoid initiating empagliflozin in patients with concurrent urinary tract infection (UTI).
- •patients with eGFR <60 mL/minute/1.73 m2 will be excluded.
- •Patients with contraindication to empagliflozin usage which include
- •eGFR <30 mL/minute/1.73 m2
- •Hypersensitivity (eg, angioedema) to empagliflozin
结局指标
主要结局
serum Brain Natriuretic Peptide (BNP) in pg/mL
时间窗: Day1 and on day 90
次要结局
- Change in left ventricular ejection fraction (LVEF) measured by M-mode echocardiography(on Day1 and on day 90)
- and Global Longitudinal Strain (GLS) measured by speckle-tracking echocardiography(Day1 and on day 90)
研究者
研究点 (1)
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