ArrhythmiaPhase 4NCT03895411
Efficacy and Safety of Sotalol in Children With Arrhythmia
A Phase 4 study testing sotalol, Propafenone and betaloc in people with Arrhythmia, run by Shengjing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- sotalol, Propafenone and betaloc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Aug 2019to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shenjing Hospital
Shenyang, Liaoning, 110004
Hong Wang, MD, 86-18940251677, wanghong_64@sina.com
About this study
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
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.
Read the 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.
- Conditions
- Arrhythmia
- Being tested
- sotalol, Propafenone, betaloc
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sotalolDrug
Oral sotalol 2.5mg/kg/time, per 12h
PropafenoneDrug
Oral Propafenone 5mg/kg/time, pre 8h
betalocDrug
Oral betaloc 0.5mg/kg/time ,pre 12h
| Study group | Role | What they receive |
|---|---|---|
| Sotalol | Experimental | Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc Receives: Drug: sotalol; Drug: betaloc |
| Propafenone | Active comparator | Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc Receives: Drug: Propafenone; Drug: betaloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT interval of ECG
Measured: 1 week
QT interval of ECG
Measured: 3 month
Secondary outcomes (9)
Blood pressure
Measured: 1 week, 3 month
Red Blood Cell (RBC)
The indicator is obtained through blood routine.
Measured: 1 week, 3 month
Wed Blood Cell (WBC)
The indicator is obtained through blood routine.
Measured: 1 week, 3 month
Hemoglobin
The indicator is obtained through blood routine.
Measured: 1 week, 3 month
Platelet
The indicator is obtained through blood routine.
Measured: 1 week, 3 month
Albumin
The indicator is obtained through liver function test.
Measured: 1 week, 3 month
Alanine aminotransferase (ALT)
The indicator is obtained through liver function test.
Measured: 1 week, 3 month
Aspertate aminotransferase (AST)
The indicator is obtained through liver function test.
Measured: 1 week, 3 month
Creatinine
The indicator is obtained through kidney function test.
Measured: 1 week, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study startAug 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Wang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895411
- Sponsor's protocol ID
- SJEX001
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03895411
- Acronym / sponsor ID
- SJEX001
- Conditions
- Arrhythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotalol | Experimental | Drug: sotalol, Drug: betalocOral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc |
| Propafenone | Active comparator | Drug: Propafenone, Drug: betalocOral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sotalolOral sotalol 2.5mg/kg/time, per 12h | Drug | Sotalol |
| PropafenoneOral Propafenone 5mg/kg/time, pre 8h | Drug | Propafenone |
| betalocOral betaloc 0.5mg/kg/time ,pre 12h | Drug | Propafenone, Sotalol |
Primary outcome
QT interval of ECG
Time frame: 1 week
QT interval of ECG
Time frame: 3 month
9 secondary outcomes
Blood pressure
Time frame: 1 week, 3 month
Red Blood Cell (RBC)
Time frame: 1 week, 3 month
Wed Blood Cell (WBC)
Time frame: 1 week, 3 month
Hemoglobin
Time frame: 1 week, 3 month
Platelet
Time frame: 1 week, 3 month
Albumin
Time frame: 1 week, 3 month
Alanine aminotransferase (ALT)
Time frame: 1 week, 3 month
Aspertate aminotransferase (AST)
Time frame: 1 week, 3 month
Creatinine
Time frame: 1 week, 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sotalol, Propafenone and betaloc in people with Arrhythmia, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Wang, MD (86-18940251677, wanghong_64@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT interval of ECG (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.