Efficacy and Safety of Sotalol in Children With Arrhythmia (NCT03895411) | Clinical Trial Compass
UnknownPhase 4
Efficacy and Safety of Sotalol in Children With Arrhythmia
China500 participantsStarted 2019-08
Plain-language summary
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.
Who can participate
Age range14 Years
SexALL
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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%;