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
Sponsor study identifier
interventional
500
1 country
1
Study Start
August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2020
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Study Completion
December 2022
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2019
Actual (reported)March 29, 2019
Actual (reported)August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
QT interval of ECG
1 week
QT interval of ECG
3 month
Blood pressure
1 week, 3 month
Red Blood Cell (RBC)
1 week, 3 month
Wed Blood Cell (WBC)
1 week, 3 month
Hemoglobin
1 week, 3 month
Platelet
1 week, 3 month
Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc
Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc
Oral sotalol 2.5mg/kg/time, per 12h
Oral Propafenone 5mg/kg/time, pre 8h
Shenjing Hospital
Shenyang, Liaoning, 110004, China
First Submitted
March 25, 2019
First Posted
March 29, 2019
Study Start
August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Atorvastatin For The Reduction Of Ventricular Arrhythmias
Oral betaloc 0.5mg/kg/time ,pre 12h
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December 2020
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 29, 2019
Record last verified: 2019-03
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Source: ClinicalTrials.gov.
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