Efficacy and Safety of Sotalol in Children With Arrhythmia

• Sponsor: Shengjing Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03895411
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40
• Patients Per Site Per Month: 12.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Drug: sotalol; Drug: Propafenone; Drug: betaloc	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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: Propafenone; Oral Propafenone 5mg/kg/time, pre 8h; Drug: betaloc; Oral betaloc 0.5mg/kg/time ,pre 12h

Outcome Measures

Primary Outcome Measures

1. QT interval of ECG [1 week]

2. QT interval of ECG [3 month]

Secondary Outcome Measures

1. Blood pressure [1 week, 3 month]

2. Red Blood Cell (RBC) [1 week, 3 month]

   The indicator is obtained through blood routine.

3. Wed Blood Cell (WBC) [1 week, 3 month]

   The indicator is obtained through blood routine.

4. Hemoglobin [1 week, 3 month]

   The indicator is obtained through blood routine.

5. Platelet [1 week, 3 month]

   The indicator is obtained through blood routine.

6. Albumin [1 week, 3 month]

   The indicator is obtained through liver function test.

7. Alanine aminotransferase (ALT) [1 week, 3 month]

   The indicator is obtained through liver function test.

8. Aspertate aminotransferase (AST) [1 week, 3 month]

   The indicator is obtained through liver function test.

9. Creatinine [1 week, 3 month]

   The indicator is obtained through kidney function test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenjing Hospital	Shenyang	Liaoning	China	110004

Sponsors and Collaborators

• Shengjing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Wang, Professor, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT03895411
• Other Study ID Numbers: SJEX001
• First Posted: Mar 29, 2019
• Last Update Posted: Mar 29, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Sotalol; Propafenone; Metoprolol

Study Results

No Results Posted as of Mar 29, 2019