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Efficacy and Safety of Sotalol in Children With Arrhythmia

NCT ID: NCT03895411

Last Updated: 2019-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sotalol

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

Group Type EXPERIMENTAL

sotalol

Intervention Type DRUG

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

betaloc

Intervention Type DRUG

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

Propafenone

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

Group Type ACTIVE_COMPARATOR

Propafenone

Intervention Type DRUG

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

betaloc

Intervention Type DRUG

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

Interventions

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sotalol

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

Intervention Type DRUG

Propafenone

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

Intervention Type DRUG

betaloc

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

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hong Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shenjing Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

Central Contacts

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Hong Wang, MD

Role: CONTACT

Phone: 86-18940251677

Email: [email protected]

Facility Contacts

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Hong Wang, MD

Role: primary

Other Identifiers

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SJEX001

Identifier Type: -

Identifier Source: org_study_id