Efficacy and Safety of Sotalol in Children With Arrhythmia

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

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.

Study Overview

• Status: Unknown
• Conditions: Arrhythmia
• Intervention / Treatment: Drug: sotalol; Drug: betaloc; Drug: Propafenone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hong Wang, MD; Phone Number: 86-18940251677; Email: wanghong_64@sina.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shenjing Hospital
      • Contact: Hong Wang, MD; Phone Number: 86-18940251677; Email: wanghong_64@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sotalol; Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc	Drug: sotalol; Oral sotalol 2.5mg/kg/time, per 12h; Drug: betaloc; Oral betaloc 0.5mg/kg/time ,pre 12h
Active Comparator: Propafenone; Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc	Drug: betaloc; Oral betaloc 0.5mg/kg/time ,pre 12h; Drug: Propafenone; Oral Propafenone 5mg/kg/time, pre 8h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
QT interval of ECG	1 week
QT interval of ECG	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		1 week, 3 month
Red Blood Cell (RBC)	The indicator is obtained through blood routine.	1 week, 3 month
Wed Blood Cell (WBC)	The indicator is obtained through blood routine.	1 week, 3 month
Hemoglobin	The indicator is obtained through blood routine.	1 week, 3 month
Platelet	The indicator is obtained through blood routine.	1 week, 3 month
Albumin	The indicator is obtained through liver function test.	1 week, 3 month
Alanine aminotransferase (ALT)	The indicator is obtained through liver function test.	1 week, 3 month
Aspertate aminotransferase (AST)	The indicator is obtained through liver function test.	1 week, 3 month
Creatinine	The indicator is obtained through kidney function test.	1 week, 3 month

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol; Sotalol; Propafenone
• Other Study ID Numbers: SJEX001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No