NCT04837261

Brief 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. Primary outcome is incidence of recurrent SVT in infants after 4 months of antiarrhythmic medication compared to retrospectively reviewed cohort.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

April 7, 2021

Last Update Submit

November 17, 2025

Conditions

Supraventricular Tachycardia

Keywords

Tachycardia, SupraventricularAnti-Arrhythmia AgentsArrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Recurrence of SVT after antiarrhythmic medication

    1 year follow-up

Secondary Outcomes (3)

  • Proportion of participants with treatment failure

    4 months of antiarrhythmic medication

  • Prevalence of adverse events

    4 months of antiarrhythmic medication

  • Recurrence of SVT after one year follow-up

    5 year

Interventions

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

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants age less than 6 months with SVT due to AVRT or AVNRT

You may qualify if:

  • Age 6 months or less
  • Documented SVT due to AVRT or AVNRT

You may not qualify if:

  • Age \> 6 months
  • Ectopic atrial tachycardia
  • Atrial flutter
  • Atrial fibrillation
  • Permanent junctional reciprocating tachycardia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Central Finland Central Hospital

Jyväskylä, Central Finland, 40620, Finland

Location

Kajaani Central Hospital

Kajaani, Kainuu, 87300, Finland

Location

Hämeenlinna Central Hospital

Hämeenlinna, Kanta-Häme, 13530, Finland

Location

Kokkola Central Hopsital

Kokkola, Keski-Pohjanmaa, 67200, Finland

Location

Lapland Central Hospital

Rovaniemi, Lapland, 96101, Finland

Location

Oulu University Hospital

Oulu, North Ostrobothnia, 90220, Finland

Location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

Lahti Central Hospital

Lahti, Paijat-Hame Region, 15850, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33520, Finland

Location

Vaasa Central Hospital

Vaasa, Pohjanmaa, 65130, Finland

Location

North Karelia Central Hospital

Joensuu, Pohjois-Karjala, 80210, Finland

Location

Kymenlaakso Central Hospital

Kotka, Region of Kymenlaakso, 48210, Finland

Location

Sakunta Central Hospital

Pori, Satakunta, 28500, Finland

Location

South Karelia Central Hospital

Lappeenranta, South Karelia Region, 53130, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, South Ostrobothnia, 60220, Finland

Location

Mikkeli Central Hospital

Mikkeli, South Savo, 50100, Finland

Location

Turku University Hospital

Turku, Southwest, 20521, Finland

Location

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Tachycardia, SupraventricularArrhythmias, Cardiac

Interventions

PropranololFlecainideAmiodarone

Condition Hierarchy (Ancestors)

TachycardiaHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tuija Poutanen, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 8, 2021

Study Start

April 15, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(18)