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Efficacy and Safety of Sotalol in Children With Arrhythmia

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ClinicalTrials.gov Identifier: NCT03895411
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Hong Wang, Shengjing Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022


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




Primary Outcome Measures :
  1. QT interval of ECG [ Time Frame: 1 week ]
  2. QT interval of ECG [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 1 week, 3 month ]
  2. Red Blood Cell (RBC) [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through blood routine.

  3. Wed Blood Cell (WBC) [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through blood routine.

  4. Hemoglobin [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through blood routine.

  5. Platelet [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through blood routine.

  6. Albumin [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through liver function test.

  7. Alanine aminotransferase (ALT) [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through liver function test.

  8. Aspertate aminotransferase (AST) [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through liver function test.

  9. Creatinine [ Time Frame: 1 week, 3 month ]
    The indicator is obtained through kidney function test.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895411


Contacts
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Contact: Hong Wang, MD 86-18940251677 wanghong_64@sina.com

Locations
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China, Liaoning
Shenjing Hospital Not yet recruiting
Shenyang, Liaoning, China, 110004
Contact: Hong Wang, MD    86-18940251677    wanghong_64@sina.com   
Sponsors and Collaborators
Shengjing Hospital

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Responsible Party: Hong Wang, Professor, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT03895411     History of Changes
Other Study ID Numbers: SJEX001
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Sotalol
Propafenone
Metoprolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Antihypertensive Agents
Adrenergic beta-1 Receptor Antagonists