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Efficacy and Safety of Sotalol in Children With Arrhythmia

Primary Purpose

Arrhythmia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sotalol
Propafenone
betaloc
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia

Eligibility Criteria

undefined - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shenjing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sotalol

Propafenone

Arm Description

Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc

Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc

Outcomes

Primary Outcome Measures

QT interval of ECG
QT interval of ECG

Secondary Outcome Measures

Blood pressure
Red Blood Cell (RBC)
The indicator is obtained through blood routine.
Wed Blood Cell (WBC)
The indicator is obtained through blood routine.
Hemoglobin
The indicator is obtained through blood routine.
Platelet
The indicator is obtained through blood routine.
Albumin
The indicator is obtained through liver function test.
Alanine aminotransferase (ALT)
The indicator is obtained through liver function test.
Aspertate aminotransferase (AST)
The indicator is obtained through liver function test.
Creatinine
The indicator is obtained through kidney function test.

Full Information

First Posted
March 25, 2019
Last Updated
March 27, 2019
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03895411
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sotalol
Arm Type
Experimental
Arm Description
Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc
Arm Title
Propafenone
Arm Type
Active Comparator
Arm Description
Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc
Intervention Type
Drug
Intervention Name(s)
sotalol
Intervention Description
Oral sotalol 2.5mg/kg/time, per 12h
Intervention Type
Drug
Intervention Name(s)
Propafenone
Intervention Description
Oral Propafenone 5mg/kg/time, pre 8h
Intervention Type
Drug
Intervention Name(s)
betaloc
Intervention Description
Oral betaloc 0.5mg/kg/time ,pre 12h
Primary Outcome Measure Information:
Title
QT interval of ECG
Time Frame
1 week
Title
QT interval of ECG
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
1 week, 3 month
Title
Red Blood Cell (RBC)
Description
The indicator is obtained through blood routine.
Time Frame
1 week, 3 month
Title
Wed Blood Cell (WBC)
Description
The indicator is obtained through blood routine.
Time Frame
1 week, 3 month
Title
Hemoglobin
Description
The indicator is obtained through blood routine.
Time Frame
1 week, 3 month
Title
Platelet
Description
The indicator is obtained through blood routine.
Time Frame
1 week, 3 month
Title
Albumin
Description
The indicator is obtained through liver function test.
Time Frame
1 week, 3 month
Title
Alanine aminotransferase (ALT)
Description
The indicator is obtained through liver function test.
Time Frame
1 week, 3 month
Title
Aspertate aminotransferase (AST)
Description
The indicator is obtained through liver function test.
Time Frame
1 week, 3 month
Title
Creatinine
Description
The indicator is obtained through kidney function test.
Time Frame
1 week, 3 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%; Suffering from bronchial asthma; Resting sinus heart rate (HR) in newborns <90 bpm; -8 yrs <80 bpm; ≥ 8 yrs <60 bpm; Corrected QT Interval (QTc) ≥ 450ms; II ° -III ° atrioventricular block (AVB); Severe liver, renal dysfunction, acute myocardial infarction, acute myocarditis, electrolyte imbalance have not been corrected; The child has undergone major surgery in the past 4 weeks; The child has participated in other clinical trials in the past 4 weeks; The child has digestive, nervous, circulatory, kidney or liver disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Wang, MD
Phone
86-18940251677
Email
wanghong_64@sina.com
Facility Information:
Facility Name
Shenjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Wang, MD
Phone
86-18940251677
Email
wanghong_64@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

Efficacy and Safety of Sotalol in Children With Arrhythmia

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