Multicenter Clinical Study of Therapeutic Effect of Sotalol on Children With Arrhythmia (Paroxysmal Supraventricular Tachycardia, Paroxysmal Atrial Tachycardia, Ventricular Tachycardia, Idiopathic Ventricular Tachycardia, Premature Ventricular Contraction ) in Children Aged From 0d to 14 Yrs
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- QT interval of ECG
研究概览
简要总结
This study aims to investigate the efficacy and safety of oral sotalol alone or combination with other anti-arrhythmic medicines in the treatment of arrhythmias in children. The study will regularly monitor the Holter, electrocardiogram (ECG), Echocardiography (Echo), blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, N-terminal pro-brain natriuretic peptide (NT pro-BNP), etc, before and after receive sotalol therapy. Compare the degree of arrhythmia improvement in patients and the side effects after oral sotalol.
详细描述
Monitoring the Holter, ECG, Echocardiography , blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, NT pro-BNP beforehand. Eligible patients should stop all anti-arrhythmia drugs and digitalis, tricyclic antidepressants, beta blockers or calcium antagonists for at least 5 half-lives, and then do Holter. Randomly grouped. Judging the results according to the situation before and after oral sotalol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 0 day to 14 year-old
- •Diagnosis of tachycardia (paroxysmal supraventricular tachycardia, paroxysmal atrial tachycardia, ventricular tachycardia, idiopathic ventricular tachycardia, premature ventricular contraction) and had an episode within 3 months; Premature Ventricular Contractions (PVC) (total 10000 times/d, or>5000 times/d with multiple source PVC, or total > 3000 times/d but with paired PVC+ multiple source PVC, or ventricular tachycardia);
- •Although PVC≤ 10000 times/d, but there are obvious symptoms such as palpitation, chest tightness, fatigue, dizziness and other symptoms that need improvement.
- •Signed informed consent before the trial
- •Good compliance
排除标准
- •Heart failure that is ineffective in conventional treatment;
- •Left ventricular ejection fraction (LVEF) ≤ 50%;
- •Suffering from bronchial asthma;
- •Resting sinus heart rate (HR) in newborns <90 bpm; -8 yrs <80 bpm; ≥ 8 yrs <60 bpm;
- •Corrected QT Interval (QTc) ≥ 450ms;
- •II ° -III ° atrioventricular block (AVB);
- •Severe liver, renal dysfunction, acute myocardial infarction, acute myocarditis, electrolyte imbalance have not been corrected;
- •The child has undergone major surgery in the past 4 weeks;
- •The child has participated in other clinical trials in the past 4 weeks;
- •The child has digestive, nervous, circulatory, kidney or liver disease
研究组 & 干预措施
Sotalol
Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc
干预措施: sotalol (Drug)
Sotalol
Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc
干预措施: betaloc (Drug)
Propafenone
Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc
干预措施: Propafenone (Drug)
Propafenone
Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc
干预措施: betaloc (Drug)
结局指标
主要结局
QT interval of ECG
时间窗: 3 month
次要结局
- Hemoglobin(1 week, 3 month)
- Aspertate aminotransferase (AST)(1 week, 3 month)
- Blood pressure(1 week, 3 month)
- Wed Blood Cell (WBC)(1 week, 3 month)
- Platelet(1 week, 3 month)
- Creatinine(1 week, 3 month)
- Red Blood Cell (RBC)(1 week, 3 month)
- Albumin(1 week, 3 month)
- Alanine aminotransferase (ALT)(1 week, 3 month)