Supraventricular TachycardiaNCT03528616
Management of Supraventricular Tachycardia of Children
An observational study of Supraventricular Tachycardia, run by Assiut University.
Trial summary
Supraventricular tachycardia (SVT) is defined as an abnormally rapid heart rhythm originating above the ventricles. It usually has narrow complex tachycardia but this is not always the case. Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- adenosine,Propranolol,flecainide, amiodarone, propranolol, digoxin and procainamide.
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 30 Nov 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: prospective observational study
Who may be able to join
- Cases of SVT who will be admitted to Assiut University Children hospital during the period between May,2018 to May,2019.
Who cannot join
- newborns up to one month age
About this study
Official title: Management of Supraventricular Tachycardia of Children Admitted to Assiut University Children Hospital(Clinical Audit)
- Supraventricular tachycardia (SVT) is defined as an abnormally rapid heart rhythm originating above the ventricles. It usually has narrow complex tachycardia but this is not always the case. Conventionally, atrial flutter and fibrillation are excluded from this group.ventricular tachycardia is the most common rhythm disturbance seen in children.(2) Most general practitioners will deal with a case at some point. While in most cases ventricular tachycardia can be considered a benign rhythm disorder, special consideration needs to be given to infants, athletes and patients with Wolff-Parkinson-White syndrome.
Read the detailed description
Epidemiology Incidence of Supraventricular tachycardia is estimated to occur in 1 in 250 otherwise healthy children. About 50% of children with Supraventricular tachycardia present with the first episode in the first year of life.
After infancy there is another surge in incidence in early childhood (6-9 years) and then in adolescence.In more than 90% of infants spontaneous resolution occurs by 1 year of age but up to a third have a subsequent recurrence of Supraventricular tachycardia at a mean age of 8 years. Spontaneous resolution is uncommon (15%) in those presenting after 1 year of age.
Most children with Supraventricular tachycardia have a structurally normal heart but the prevalence of congenital heart disease in patients with Supraventricular tachycardia is substantially higher than that of the general population (9-32%).
Clinical presentation Clinical presentation depends on the age of the child and the duration of Supraventricular tachycardia.
In infants the heart rate is usually about 220 to 320 bpm and symptoms are usually nonspecific, including poor feeding, irritability, vomiting and dusky episodes. If the symptoms are unrecognised for hours or days the infant may present with heart failure or shock.In older children the heart rate is between 160 to 280 bpm and the usual presenting symptoms are palpitations, chest pain and shortness of breath. Often light-headedness and dizziness can occur; however, syncope is rare.
The frequency and duration of episodes can vary hugely, with episodes lasting a few minutes to several hours and occurring once a year to several times a day.
Physical examination is normal apart from the infant presenting in heart failure and shock.
Investigations
Diagnosis is confirmed by making an ECG recording during symptoms. Options available for this are:
Holter (24-hour ambulatory ECG) monitoring in children having daily symptoms. Cardiac event recorders in those who have brief infrequent symptoms. ECG in the emergency department (ED) in those with infrequent but prolonged symptoms allowing them to travel to ED in the event of symptoms.
ECG done during episodes is diagnostic and shows:
Tachycardia with narrow QRS complexes. P waves may not be visible. If visible, they exhibit retrograde conduction with inverted P waves.A baseline echocardiography to confirm the presence of a structurally normal heart and to ensure that,heart function is normal,is recommended.
Acute management of Supraventricular tachycardia Acute management of Supraventricular tachycardia is primarily based on use of vagal manoeuvres and/or adenosine. Sometimes other medications and occasionally direct current (DC) shock are needed.
Advanced Paediatric Life Support guidelines recommend the following approach:
Assess airway, breathing and circulation (ABC) in any child or infant presenting with Supraventricular tachycardia. Try vagal stimulation while continuing ECG monitoring. The techniques that can be used include:
Elicit the 'diving reflex' by applying a rubber glove filled with iced water on the face or wrapping the infant in a towel and immersing the face in iced water for five seconds.
One-sided carotid massage. Valsalva manoeuvre in older children. Give IV adenosine if vagal manoeuvres are unsuccessful. Start with a bolus dose of 100 micrograms/kg intravenously. If this does not work, increasing doses (200 micrograms/kg and then 300 micrograms/kg) can be given after two minutes. The maximum single dose that is given is 500 micrograms/kg (300 micrograms/kg in infants less than 1 month of age), up to a maximum of 12 mg.
In a hemodynamically stable child not responding to adenosine, alternative medications should be used based on advice by a paediatric cardiologist. The options available include flecainide, amiodarone, propranolol, digoxin and procainamide.
verapamil has been associated with irreversible hypotension and asystole in infants and should not be used in this age group.
Wide complex Supraventricular tachycardia(i.e Supraventricular tachycardia with aberrant conduction) is uncommon in infants and children.
In an infant or child with Supraventricular tachycardia and in shock the best treatment option is synchronised DC cardioversion starting at a dose of 1 joule/kg and increasing to 2 joules/kg if necessary.
Long-term management Long-term management is dependent on a number of factors, including the age of patient, duration and frequency of episodes and presence of ventricular dysfunction. Management is carried out under the supervision of a pediatric cardiologist.In children with infrequent, mild and self-limiting episodes, usually no treatment is needed.In children in whom the episodes are frequent, prolonged, difficult to terminate or interfering with sports participation, treatment is indicated. Treatment options include medications or transcatheter ablation.
- Medical treatment The purpose of using anti-arrhythmic drugs is to slow conduction, preferentially within one limb of the re-entrant circuit and therefore terminate the tachycardia. Treatment options include digoxin, beta-blockers, calcium-channel blockers and the sodium-channel blocker, flecainide. While there is significant variation in practice, the majority of European centers use flecainide or atenolol as the first choice of drug for the prevention of recurrent Supraventricular tachycardia. There is little difference in the efficacy of various medications and a randomised controlled trial comparing digoxin and propranolol found no difference in recurrence of Supraventricular tachycardia in the two groups. While any of the anti-arrhythmics can be used to initiate treatment.
- Ablation treatment Management of Supraventricular tachycardia has been revolutionised with the development of transcatheter ablation which is now considered standard treatment for older children and adolescents.
Radiofrequency (RF) is the preferred energy source for paediatric arrhythmias and catheter ablation is only chosen if two or more anti-arrhythmic drugs have failed.
An alternative to RF is cryoablation, which is safer and minimises the risk of heart block during ablation. However, it is associated with a higher Supraventricular tachycardia recurrence rate and therefore most centers use cryoablation in cases where RF ablation is considered a higher risk.
Sports participation and general advice Patients and parents should be reassured that Supraventricular tachycardia is typically not life-threatening but can be life-altering.
Parents and patients should be taught age-appropriate vagal manoeuvres and indications for requesting assistance from emergency services. These include:
Prolonged symptoms. Episode not terminated by vagal manoeuvres. Syncope.
Routine school physical activities including recreational sports participation are allowed.Much more caution needs to be exercised in those participating in competitive athletics and high-speed or contact sports. Guidelines issued by the American Heart Association recommend the following:
Asymptomatic athletes with structurally normal hearts and exercise-induced Supraventricular tachycardia prevented by medical treatment can participate in all competitive sport.
Athletes who have had successful transcatheter ablation and are asymptomatic with no inducible arrhythmia can return to full competition.
Fetal supraventricular tachycardia It accounts for 60%-80% of fetal tachyarrhythmias, with prevalence ranging from 1 in 1,000 to 1 in 25,000 pregnancies.
Clinical presentation is variable. Intermittent Supraventricular tachycardia may have no hemodynamic effect, while persistent Supraventricular tachycardia may result in fetal hydrops due to high-output cardiac failure.
Risk of developing hydrops is related to the age of the fetus (the younger is more susceptible) and duration of Supraventricular tachycardia.
Diagnosis is made by fetal echocardiography using M mode and Doppler. Treatment is transplacental therapy with anti-arrhythmics such as digoxin and flecainide.
Prognosis:
In the absence of structural heart disease or cardiomyopathy, the prognosis of Supraventricular tachycardia is excellent.
- Conditions
- Supraventricular Tachycardia
- Being tested
- adenosine,Propranolol,flecainide, amiodarone, propranolol, digoxin and procainamide.
- Medical subject headings
- Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenosine,Propranolol,flecainide, amiodarone, propranolol, digoxin and procainamide.Drug
drugs used for treatment of supraventricular tachycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate management of SVT in the cardiology unit of Assiut University Children Hospital according to international guidelines by using pharmacological and non pharmacological treatments.
Descriptive sheet of the study checklist that will be asked about in all cases: Clinical examination and ECG at presentation,Physical maneuvers(vagal stimulation),Drug therapy including:adenosine and other antiarrythmic drugs as Flecainide,propranolol,amiodarone,digoxin and verapamil.
Appropriate dose of drugs,Putting on monitor ECG during treatment,Synchronized DC cardioversion in hemodynamically unstable cases.
Yes ,No ,℅ of the folowing, Clinical examination and ECG at presentation Vagal manoeuvers,diving reflex,One side carotid massage,Valsalva manoeuvre Drug therapy Adenosine only,Flecainide only,Propranolol and Amiodarone,Amiodarone only Digoxin only,Digoxin then Amiodarone, Verapamil Maintain ECG monitoring,Synchronized DC cardioversion. These data will be collected and revised to show how would doctors in the cardiology unit of Assiut University Children Hospital manage SVT according to the international guinternational guidelines.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start15 May 2018 (estimated)
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528616
- Sponsor's protocol ID
- SVT
- Status last verified
- May 2018
- First submitted
- 20 Apr 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sawhney V, Corden B, Abdul-Mukith K, Harris T, Schilling RJ. Are patients admitted to emergency departments with regular supraventricular tachycardia (SVT) treated appropriately? Clin Med (Lond). 2013 Apr;13(2):146-8. doi: 10.7861/clinmedicine.13-2-146.
PubMed 23681861
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Supraventricular Tachycardia of Children Admitted to Assiut University Children Hospital(Clinical Audit)
- ClinicalTrials.gov ID
- NCT03528616
- Acronym / sponsor ID
- SVT
- Conditions
- Supraventricular Tachycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 18 May 2018 (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.
- Supraventricular tachycardia (SVT) is defined as an abnormally rapid heart rhythm originating above the ventricles. It usually has narrow complex tachycardia but this is not always the case. Conventionally, atrial flutter and fibrillation are excluded from this group.ventricular tachycardia is the most common rhythm disturbance seen in children.(2) Most general practitioners will deal with a case at some point. While in most cases ventricular tachycardia can be considered a benign rhythm disorder, special consideration needs to be given to infants, athletes and patients with Wolff-Parkinson-White syndrome.
Detailed description
Epidemiology Incidence of Supraventricular tachycardia is estimated to occur in 1 in 250 otherwise healthy children. About 50% of children with Supraventricular tachycardia present with the first episode in the first year of life.
After infancy there is another surge in incidence in early childhood (6-9 years) and then in adolescence.In more than 90% of infants spontaneous resolution occurs by 1 year of age but up to a third have a subsequent recurrence of Supraventricular tachycardia at a mean age of 8 years. Spontaneous resolution is uncommon (15%) in those presenting after 1 year of age.
Most children with Supraventricular tachycardia have a structurally normal heart but the prevalence of congenital heart disease in patients with Supraventricular tachycardia is substantially higher than that of the general population (9-32%).
Clinical presentation Clinical presentation depends on the age of the child and the duration of Supraventricular tachycardia.
In infants the heart rate is usually about 220 to 320 bpm and symptoms are usually nonspecific, including poor feeding, irritability, vomiting and dusky episodes. If the symptoms are unrecognised for hours or days the infant may present with heart failure or shock.In older children the heart rate is between 160 to 280 bpm and the usual presenting symptoms are palpitations, chest pain and shortness of breath. Often light-headedness and dizziness can occur; however, syncope is rare.
The frequency and duration of episodes can vary hugely, with episodes lasting a few minutes to several hours and occurring once a year to several times a day.
Physical examination is normal apart from the infant presenting in heart failure and shock.
Investigations
Diagnosis is confirmed by making an ECG recording during symptoms. Options available for this are:
Holter (24-hour ambulatory ECG) monitoring in children having daily symptoms. Cardiac event recorders in those who have brief infrequent symptoms. ECG in the emergency department (ED) in those with infrequent but prolonged symptoms allowing them to travel to ED in the event of symptoms.
ECG done during episodes is diagnostic and shows:
Tachycardia with narrow QRS complexes. P waves may not be visible. If visible, they exhibit retrograde conduction with inverted P waves.A baseline echocardiography to confirm the presence of a structurally normal heart and to ensure that,heart function is normal,is recommended.
Acute management of Supraventricular tachycardia Acute management of Supraventricular tachycardia is primarily based on use of vagal manoeuvres and/or adenosine. Sometimes other medications and occasionally direct current (DC) shock are needed.
Advanced Paediatric Life Support guidelines recommend the following approach:
Assess airway, breathing and circulation (ABC) in any child or infant presenting with Supraventricular tachycardia. Try vagal stimulation while continuing ECG monitoring. The techniques that can be used include:
Elicit the 'diving reflex' by applying a rubber glove filled with iced water on the face or wrapping the infant in a towel and immersing the face in iced water for five seconds.
One-sided carotid massage. Valsalva manoeuvre in older children. Give IV adenosine if vagal manoeuvres are unsuccessful. Start with a bolus dose of 100 micrograms/kg intravenously. If this does not work, increasing doses (200 micrograms/kg and then 300 micrograms/kg) can be given after two minutes. The maximum single dose that is given is 500 micrograms/kg (300 micrograms/kg in infants less than 1 month of age), up to a maximum of 12 mg.
In a hemodynamically stable child not responding to adenosine, alternative medications should be used based on advice by a paediatric cardiologist. The options available include flecainide, amiodarone, propranolol, digoxin and procainamide.
verapamil has been associated with irreversible hypotension and asystole in infants and should not be used in this age group.
Wide complex Supraventricular tachycardia(i.e Supraventricular tachycardia with aberrant conduction) is uncommon in infants and children.
In an infant or child with Supraventricular tachycardia and in shock the best treatment option is synchronised DC cardioversion starting at a dose of 1 joule/kg and increasing to 2 joules/kg if necessary.
Long-term management Long-term management is dependent on a number of factors, including the age of patient, duration and frequency of episodes and presence of ventricular dysfunction. Management is carried out under the supervision of a pediatric cardiologist.In children with infrequent, mild and self-limiting episodes, usually no treatment is needed.In children in whom the episodes are frequent, prolonged, difficult to terminate or interfering with sports participation, treatment is indicated. Treatment options include medications or transcatheter ablation.
- Medical treatment The purpose of using anti-arrhythmic drugs is to slow conduction, preferentially within one limb of the re-entrant circuit and therefore terminate the tachycardia. Treatment options include digoxin, beta-blockers, calcium-channel blockers and the sodium-channel blocker, flecainide. While there is significant variation in practice, the majority of European centers use flecainide or atenolol as the first choice of drug for the prevention of recurrent Supraventricular tachycardia. There is little difference in the efficacy of various medications and a randomised controlled trial comparing digoxin and propranolol found no difference in recurrence of Supraventricular tachycardia in the two groups. While any of the anti-arrhythmics can be used to initiate treatment.
- Ablation treatment Management of Supraventricular tachycardia has been revolutionised with the development of transcatheter ablation which is now considered standard treatment for older children and adolescents.
Radiofrequency (RF) is the preferred energy source for paediatric arrhythmias and catheter ablation is only chosen if two or more anti-arrhythmic drugs have failed.
An alternative to RF is cryoablation, which is safer and minimises the risk of heart block during ablation. However, it is associated with a higher Supraventricular tachycardia recurrence rate and therefore most centers use cryoablation in cases where RF ablation is considered a higher risk.
Sports participation and general advice Patients and parents should be reassured that Supraventricular tachycardia is typically not life-threatening but can be life-altering.
Parents and patients should be taught age-appropriate vagal manoeuvres and indications for requesting assistance from emergency services. These include:
Prolonged symptoms. Episode not terminated by vagal manoeuvres. Syncope.
Routine school physical activities including recreational sports participation are allowed.Much more caution needs to be exercised in those participating in competitive athletics and high-speed or contact sports. Guidelines issued by the American Heart Association recommend the following:
Asymptomatic athletes with structurally normal hearts and exercise-induced Supraventricular tachycardia prevented by medical treatment can participate in all competitive sport.
Athletes who have had successful transcatheter ablation and are asymptomatic with no inducible arrhythmia can return to full competition.
Fetal supraventricular tachycardia It accounts for 60%-80% of fetal tachyarrhythmias, with prevalence ranging from 1 in 1,000 to 1 in 25,000 pregnancies.
Clinical presentation is variable. Intermittent Supraventricular tachycardia may have no hemodynamic effect, while persistent Supraventricular tachycardia may result in fetal hydrops due to high-output cardiac failure.
Risk of developing hydrops is related to the age of the fetus (the younger is more susceptible) and duration of Supraventricular tachycardia.
Diagnosis is made by fetal echocardiography using M mode and Doppler. Treatment is transplacental therapy with anti-arrhythmics such as digoxin and flecainide.
Prognosis:
In the absence of structural heart disease or cardiomyopathy, the prognosis of Supraventricular tachycardia is excellent.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- prospective observational study
Key inclusion criteria (1 listed)
- Cases of SVT who will be admitted to Assiut University Children hospital during the period between May,2018 to May,2019.
Key exclusion criteria (1 listed)
- newborns up to one month age
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 |
|---|---|---|
| adenosine,Propranolol,flecainide, amiodarone, propranolol, digoxin and procainamide.drugs used for treatment of supraventricular tachycardia | Drug | – |
Primary outcome
Evaluate management of SVT in the cardiology unit of Assiut University Children Hospital according to international guidelines by using pharmacological and non pharmacological treatments.
Time frame: one year
Descriptive sheet of the study checklist that will be asked about in all cases: Clinical examination and ECG at presentation,Physical maneuvers(vagal stimulation),Drug therapy including:adenosine and other antiarrythmic drugs as Flecainide,propranolol,amiodarone,digoxin and verapamil. Appropriate dose of drugs,Putting on monitor ECG during treatment,Synchronized DC cardioversion in hemodynamically unstable cases. Yes ,No ,℅ of the folowing, Clinical examination and ECG at presentation Vagal manoeuvers,diving reflex,One side carotid massage,Valsalva manoeuvre Drug therapy Adenosine only,Flecainide only,Propranolol and Amiodarone,Amiodarone only Digoxin only,Digoxin then Amiodarone, Verapamil Maintain ECG monitoring,Synchronized DC cardioversion. These data will be collected and revised to show how would doctors in the cardiology unit of Assiut University Children Hospital manage SVT according to the international guinternational guidelines.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Background: PubMed 23681861Sawhney V, Corden B, Abdul-Mukith K, Harris T, Schilling RJ. Are patients admitted to emergency departments with regular supraventricular tachycardia (SVT) treated appropriately? Clin Med (Lond). 2013 Apr;13(2):146-8. doi: 10.7861/clinmedicine.13-2-146.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Tachycardia, run by Assiut University.
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 1 inclusion and 1 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate management of SVT in the cardiology unit of Assiut University Children Hospital according to international guidelines by using pharmacological and non pharmacological treatments. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528616, which also lists 1 linked publication.
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 18 May 2018.