Clinical trial NCT04837261: Shortening Duration of Antiarrhythmic Medication for SVT in Infants
Official title: Shortening Duration of Antiarrhythmic Medication for SVT in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Supraventricular Tachycardia
Keywords: Tachycardia, Supraventricular
Anti-Arrhythmia Agents
Arrhythmias, Cardiac
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Kuopio University Hospital
name: Oulu University Hospital
name: Turku University Hospital
First posted: 2021-04-08
Enrollment: 70
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants age less than 6 months with SVT due to AVRT or AVNRT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Recurrence of SVT after antiarrhythmic medication
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Proportion of participants with treatment failure
timeFrame: 4 months of antiarrhythmic medication
measure: Prevalence of adverse events
timeFrame: 4 months of antiarrhythmic medication
measure: Recurrence of SVT after one year follow-up
timeFrame: 5 year
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
state: Central Finland
city: Kokkola
country: Finland
facility: Kokkola Central Hopsital
state: Central Ostrobothnia
city: Kajaani
country: Finland
facility: Kajaani Central Hospital
state: Kainuu
city: Hämeenlinna
country: Finland
facility: Hämeenlinna Central Hospital
state: Kanta-Häme
city: Rovaniemi
country: Finland
facility: Lapland Central Hospital
state: Lapland
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
state: North Karelia
city: Oulu
country: Finland
facility: Oulu University Hospital
state: North Ostrobothnia
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: North Savo
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
state: Ostrobothnia
city: Tampere
country: Finland
facility: Tampere University Hospital
state: Pirkanmaa
city: Lahti
country: Finland
facility: Lahti Central Hospital
state: Päijät-Häme
city: Kotka
country: Finland
facility: Kymenlaakso Central Hospital
state: Region Of Kymenlaakso
city: Pori
country: Finland
facility: Sakunta Central Hospital
state: Satakunta
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital
state: South Karelia
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
state: South Ostrobothnia
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
state: South Savo
city: Turku
country: Finland
facility: Turku University Hospital
state: Southwest
city: Helsinki
country: Finland
facility: Helsinki University Hospital
state: Uusimaa
Study officials:
affiliation: Tampere University Hospital
name: Tuija Poutanen, MD
role: PRINCIPAL_INVESTIGATOR
References: