NCT03895411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

March 25, 2019

Last Update Submit

March 27, 2019

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (2)

  • QT interval of ECG

    1 week

  • QT interval of ECG

    3 month

Secondary Outcomes (9)

  • Blood pressure

    1 week, 3 month

  • Red Blood Cell (RBC)

    1 week, 3 month

  • Wed Blood Cell (WBC)

    1 week, 3 month

  • Hemoglobin

    1 week, 3 month

  • Platelet

    1 week, 3 month

  • +4 more secondary outcomes

Study Arms (2)

Sotalol

EXPERIMENTAL

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

Drug: sotalolDrug: betaloc

Propafenone

ACTIVE COMPARATOR

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

Drug: PropafenoneDrug: betaloc

Interventions

sotalolDRUG

Oral sotalol 2.5mg/kg/time, per 12h

Sotalol
PropafenoneDRUG

Oral Propafenone 5mg/kg/time, pre 8h

Propafenone
betalocDRUG

Oral betaloc 0.5mg/kg/time ,pre 12h

PropafenoneSotalol

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

SotalolPropafenoneMetoprolol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPropiophenonesKetonesPhenoxypropanolaminesPropanolaminesPropanols

Central Study Contacts

Hong Wang, MD

CONTACT

86-18940251677wanghong_64@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 29, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2022

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

CN(1)