drugset / Trial / NCT03895411
Efficacy and Safety of Sotalol in Children With Arrhythmia
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-08
- Primary completion
- 2020-12
- Completion
- 2022-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | propafenone | Unknown | 5 mg/kg | Oral |
| Subject | sotalol | Small molecule | 2.5 mg/kg | Oral |
| Background | Metoprolol | Other / unclassified | 0.5 mg/kg | Oral |