Clinical trial NCT03895411: Efficacy and Safety of Sotalol in Children With Arrhythmia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arrhythmia
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 500
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 0 day to 14 year-old
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:

1. Heart failure that is ineffective in conventional treatment;
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

Primary outcomes:
measure: QT interval of ECG
timeFrame: 1 week
measure: QT interval of ECG
timeFrame: 3 month
Secondary outcomes:
measure: Blood pressure
timeFrame: 1 week, 3 month
measure: Red Blood Cell (RBC)
timeFrame: 1 week, 3 month
measure: Wed Blood Cell (WBC)
timeFrame: 1 week, 3 month
measure: Hemoglobin
timeFrame: 1 week, 3 month
measure: Platelet
timeFrame: 1 week, 3 month
measure: Albumin
timeFrame: 1 week, 3 month
measure: Alanine aminotransferase (ALT)
timeFrame: 1 week, 3 month
measure: Aspertate aminotransferase (AST)
timeFrame: 1 week, 3 month
measure: Creatinine
timeFrame: 1 week, 3 month
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenjing Hospital
state: Liaoning
Study officials:
References: