Efficacy and Safety of Sotalol in Children With Arrhythmia
NCT ID: NCT03895411
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2019-08-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sotalol
Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc
sotalol
Oral sotalol 2.5mg/kg/time, per 12h
betaloc
Oral betaloc 0.5mg/kg/time ,pre 12h
Propafenone
Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc
Propafenone
Oral Propafenone 5mg/kg/time, pre 8h
betaloc
Oral betaloc 0.5mg/kg/time ,pre 12h
Interventions
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sotalol
Oral sotalol 2.5mg/kg/time, per 12h
Propafenone
Oral Propafenone 5mg/kg/time, pre 8h
betaloc
Oral betaloc 0.5mg/kg/time ,pre 12h
Eligibility Criteria
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Inclusion Criteria
2. 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);
3. Although PVC≤ 10000 times/d, but there are obvious symptoms such as palpitation, chest tightness, fatigue, dizziness and other symptoms that need improvement.
4. Signed informed consent before the trial
5. Good compliance
Exclusion Criteria
2. Left ventricular ejection fraction (LVEF) ≤ 50%;
3. Suffering from bronchial asthma;
4. Resting sinus heart rate (HR) in newborns \<90 bpm; -8 yrs \<80 bpm; ≥ 8 yrs \<60 bpm;
5. Corrected QT Interval (QTc) ≥ 450ms;
6. II ° -III ° atrioventricular block (AVB);
7. Severe liver, renal dysfunction, acute myocardial infarction, acute myocarditis, electrolyte imbalance have not been corrected;
8. The child has undergone major surgery in the past 4 weeks;
9. The child has participated in other clinical trials in the past 4 weeks;
10. The child has digestive, nervous, circulatory, kidney or liver disease
14 Years
ALL
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Hong Wang
Professor
Locations
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Shenjing Hospital
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SJEX001
Identifier Type: -
Identifier Source: org_study_id
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