Supraventricular TachycardiaNCT04837261
Shortening Duration of Antiarrhythmic Medication for SVT in Infants
An observational study of Supraventricular Tachycardia, run by Tampere University Hospital at 18 sites in Finland.
Trial summary
The infants diagnosed with SVT are treated with antiarrhythmic medication to prevent the recurrence of SVT. This prospective observational cohort study evaluates efficacy and safety of shortening duration of antiarrhythmic medication to four months in infants with SVT. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Supraventricular Tachycardia
- What is being tested?
- Propranolol, Flecainide and Amiodarone
- How many people
- 107 participants
- Where
- 18 sitesFinland
- Study dates
- 15 Apr 2021to 31 Jan 2024
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants age less than 6 months with SVT due to AVRT or AVNRT
Who may be able to join
- Age 6 months or less
- Documented SVT due to AVRT or AVNRT
Who cannot join
- Age > 6 months
- Ectopic atrial tachycardia
- Atrial flutter
- Atrial fibrillation
- Permanent junctional reciprocating tachycardia
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Finland18 sites
Hämeenlinna Central Hospital
Hämeenlinna, Kanta-Häme, 13530
Helsinki University Hospital
Helsinki, Uusimaa, 00029
North Karelia Central Hospital
Joensuu, Pohjois-Karjala, 80210
Central Finland Central Hospital
Jyväskylä, Central Finland, 40620
Kajaani Central Hospital
Kajaani, Kainuu, 87300
Kokkola Central Hopsital
Kokkola, Keski-Pohjanmaa, 67200
Kymenlaakso Central Hospital
Kotka, Region of Kymenlaakso, 48210
Kuopio University Hospital
Kuopio, Northern Savonia, 70029
Lahti Central Hospital
Lahti, Paijat-Hame Region, 15850
South Karelia Central Hospital
Lappeenranta, South Karelia Region, 53130
Mikkeli Central Hospital
Mikkeli, South Savo, 50100
Oulu University Hospital
Oulu, North Ostrobothnia, 90220
Sakunta Central Hospital
Pori, Satakunta, 28500
Lapland Central Hospital
Rovaniemi, Lapland, 96101
Seinäjoki Central Hospital
Seinäjoki, South Ostrobothnia, 60220
Tampere University Hospital
Tampere, Pirkanmaa, 33520
Turku University Hospital
Turku, Southwest, 20521
Vaasa Central Hospital
Vaasa, Pohjanmaa, 65130
About this study
The infants diagnosed with SVT are treated with antiarrhythmic medication to prevent the recurrence of SVT. This prospective observational cohort study evaluates efficacy and safety of shortening duration of antiarrhythmic medication to four months in infants with SVT. Primary outcome is incidence of recurrent SVT in infants after 4 months of antiarrhythmic medication compared to retrospectively reviewed cohort.
- Conditions
- Supraventricular Tachycardia
- Being tested
- Propranolol, Flecainide, Amiodarone
- Keywords
- Tachycardia, Supraventricular, Anti-Arrhythmia Agents, Arrhythmias, Cardiac
- Medical subject headings
- Tachycardia, Supraventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
3 mg/kg/d, divided in four doses when age less than 3 months and in three doses when age more than 3 months
FlecainideDrug
80 mg/m2/d
AmiodaroneDrug
Single dose of 10 mg/kg/d 10-14 days, 5 mg/kg/d
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of SVT after antiarrhythmic medication
Measured: 1 year follow-up
Secondary outcomes (3)
Proportion of participants with treatment failure
Measured: 4 months of antiarrhythmic medication
Prevalence of adverse events
Measured: 4 months of antiarrhythmic medication
Recurrence of SVT after one year follow-up
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Apr 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Tuija Poutanen, MD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837261
- Sponsor's protocol ID
- R20113
- Status last verified
- Nov 2025
- First submitted
- 7 Apr 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortening Duration of Antiarrhythmic Medication for SVT in Infants
- ClinicalTrials.gov ID
- NCT04837261
- Acronym / sponsor ID
- R20113
- Conditions
- Supraventricular Tachycardia
- Keywords
- Tachycardia, Supraventricular, Anti-Arrhythmia Agents, Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Turku University Hospital
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 Apr 2021 (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.
The infants diagnosed with SVT are treated with antiarrhythmic medication to prevent the recurrence of SVT. This prospective observational cohort study evaluates efficacy and safety of shortening duration of antiarrhythmic medication to four months in infants with SVT. Primary outcome is incidence of recurrent SVT in infants after 4 months of antiarrhythmic medication compared to retrospectively reviewed cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants age less than 6 months with SVT due to AVRT or AVNRT
Key inclusion criteria (2 listed)
- Age 6 months or less
- Documented SVT due to AVRT or AVNRT
Key exclusion criteria (5 listed)
- Age > 6 months
- Ectopic atrial tachycardia
- Atrial flutter
- Atrial fibrillation
- Permanent junctional reciprocating tachycardia
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 |
|---|---|---|
| Propranolol3 mg/kg/d, divided in four doses when age less than 3 months and in three doses when age more than 3 months | Drug | – |
| Flecainide80 mg/m2/d | Drug | – |
| AmiodaroneSingle dose of 10 mg/kg/d 10-14 days, 5 mg/kg/d | Drug | – |
Primary outcome
Recurrence of SVT after antiarrhythmic medication
Time frame: 1 year follow-up
3 secondary outcomes
Proportion of participants with treatment failure
Time frame: 4 months of antiarrhythmic medication
Prevalence of adverse events
Time frame: 4 months of antiarrhythmic medication
Recurrence of SVT after one year follow-up
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Tuija Poutanen, MD principal investigator
Tampere University Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Tachycardia, run by Tampere University Hospital at 18 sites in Finland.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Finland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recurrence of SVT after antiarrhythmic medication (time frame: 1 year follow-up). 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 20 Nov 2025.