A Phase 4 interventional study of sotalol and Propafenone in Arrhythmia, sponsored by Shengjing Hospital. Status unknown at 1 site in China. Open to participants aged Up to 14 Years. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by Shengjing Hospital · Phase 4, Interventional, and Treatment
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.
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's planned enrollment of 500 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc
Drug: sotalol · Drug: betaloc
Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc
Drug: Propafenone · Drug: betaloc
Oral sotalol 2.5mg/kg/time, per 12h
Oral Propafenone 5mg/kg/time, pre 8h
Oral betaloc 0.5mg/kg/time ,pre 12h
QT interval of ECG
Time frame: 1 week
QT interval of ECG
Time frame: 3 month
Blood pressure
Time frame: 1 week, 3 month
Red Blood Cell (RBC)
The indicator is obtained through blood routine.
Time frame: 1 week, 3 month
Wed Blood Cell (WBC)
The indicator is obtained through blood routine.
Time frame: 1 week, 3 month
Hemoglobin
The indicator is obtained through blood routine.
Time frame: 1 week, 3 month
Platelet
The indicator is obtained through blood routine.
Time frame: 1 week, 3 month
Albumin
The indicator is obtained through liver function test.
Time frame: 1 week, 3 month
Alanine aminotransferase (ALT)
The indicator is obtained through liver function test.
Time frame: 1 week, 3 month
Aspertate aminotransferase (AST)
The indicator is obtained through liver function test.
Time frame: 1 week, 3 month
Creatinine
The indicator is obtained through kidney function test.
Time frame: 1 week, 3 month
Plan to share: Undecided — Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Shengjing Hospital