Efficacy and Safety of Sotalol in Children With Arrhythmia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Arrhythmia

Intervention / Treatment
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* Drug: sotalol
* Drug: Propafenone
* Drug: betaloc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sotalol<br>Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc | Drug: sotalol<br>* Oral sotalol 2.5mg/kg/time, per 12h<br>Drug: betaloc<br>* Oral betaloc 0.5mg/kg/time ,pre 12h<br>|
| Active Comparator: Propafenone<br>Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc | Drug: Propafenone<br>* Oral Propafenone 5mg/kg/time, pre 8h<br>Drug: betaloc<br>* Oral betaloc 0.5mg/kg/time ,pre 12h<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT interval of ECG |  | 1 week | 
| QT interval of ECG |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 1 week, 3 month | 
| Red Blood Cell (RBC) | The indicator is obtained through blood routine. | 1 week, 3 month | 
| Wed Blood Cell (WBC) | The indicator is obtained through blood routine. | 1 week, 3 month | 
| Hemoglobin | The indicator is obtained through blood routine. | 1 week, 3 month | 
| Platelet | The indicator is obtained through blood routine. | 1 week, 3 month | 
| Albumin | The indicator is obtained through liver function test. | 1 week, 3 month | 
| Alanine aminotransferase (ALT) | The indicator is obtained through liver function test. | 1 week, 3 month | 
| Aspertate aminotransferase (AST) | The indicator is obtained through liver function test. | 1 week, 3 month | 
| Creatinine | The indicator is obtained through kidney function test. | 1 week, 3 month |