Shortening Duration of Antiarrhythmic Medication for SVT in Infants

NCT ID: NCT04837261

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Supraventricular Tachycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Propranolol

3 mg/kg/d, divided in four doses when age less than 3 months and in three doses when age more than 3 months

Intervention Type DRUG

Flecainide

80 mg/m2/d

Intervention Type DRUG

Amiodarone

Single dose of 10 mg/kg/d 10-14 days, 5 mg/kg/d

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tuija Poutanen, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Central Finland Central Hospital

Jyväskylä, Central Finland, Finland

Site Status

Kajaani Central Hospital

Kajaani, Kainuu, Finland

Site Status

Hämeenlinna Central Hospital

Hämeenlinna, Kanta-Häme, Finland

Site Status

Kokkola Central Hopsital

Kokkola, Keski-Pohjanmaa, Finland

Site Status

Lapland Central Hospital

Rovaniemi, Lapland, Finland

Site Status

Oulu University Hospital

Oulu, North Ostrobothnia, Finland

Site Status

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Lahti Central Hospital

Lahti, Paijat-Hame Region, Finland

Site Status

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status

Vaasa Central Hospital

Vaasa, Pohjanmaa, Finland

Site Status

North Karelia Central Hospital

Joensuu, Pohjois-Karjala, Finland

Site Status

Kymenlaakso Central Hospital

Kotka, Region of Kymenlaakso, Finland

Site Status

Sakunta Central Hospital

Pori, Satakunta, Finland

Site Status

South Karelia Central Hospital

Lappeenranta, South Karelia Region, Finland

Site Status

Seinäjoki Central Hospital

Seinäjoki, South Ostrobothnia, Finland

Site Status

Mikkeli Central Hospital

Mikkeli, South Savo, Finland

Site Status

Turku University Hospital

Turku, Southwest, Finland

Site Status

Helsinki University Hospital

Helsinki, Uusimaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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R20113

Identifier Type: -

Identifier Source: org_study_id

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