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NCT04837261 Clinical Trial

Shortening Duration of Antiarrhythmic Medication for SVT in Infants

Supraventricular Tachycardia Clinical Trial

Official title:
Shortening Duration of Antiarrhythmic Medication for SVT in Infants

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04837261
Other study ID # R20113
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2021
Est. completion date January 1, 2024

Study information
Verified date September 2021
Source Tampere University Hospital
Contact Minna Mecklin, MD
Phone +358444728153
Email minna.mecklin@pshp.fi
Is FDA regulated No
Health authority
Study type Observational

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

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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
• Flecainide
80 mg/m2/d
• Amiodarone
Single dose of 10 mg/kg/d 10-14 days, 5 mg/kg/d

Locations
Country Name City State
Finland Hämeenlinna Central Hospital Hämeenlinna Kanta-Häme
Finland Helsinki University Hospital Helsinki Uusimaa
Finland North Karelia Central Hospital Joensuu North Karelia
Finland Central Finland Central Hospital Jyväskylä Central Finland
Finland Kajaani Central Hospital Kajaani Kainuu
Finland Kokkola Central Hopsital Kokkola Central Ostrobothnia
Finland Kymenlaakso Central Hospital Kotka Region Of Kymenlaakso
Finland Kuopio University Hospital Kuopio North Savo
Finland Lahti Central Hospital Lahti Päijät-Häme
Finland South Karelia Central Hospital Lappeenranta South Karelia
Finland Mikkeli Central Hospital Mikkeli South Savo
Finland Oulu University Hospital Oulu North Ostrobothnia
Finland Sakunta Central Hospital Pori Satakunta
Finland Lapland Central Hospital Rovaniemi Lapland
Finland Seinäjoki Central Hospital Seinäjoki South Ostrobothnia
Finland Tampere University Hospital Tampere Pirkanmaa
Finland Turku University Hospital Turku Southwest
Finland Vaasa Central Hospital Vaasa Ostrobothnia

Sponsors (5)
Lead Sponsor Collaborator
Tampere University Hospital Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence of SVT after antiarrhythmic medication 1 year follow-up
Secondary Proportion of participants with treatment failure 4 months of antiarrhythmic medication
Secondary Prevalence of adverse events 4 months of antiarrhythmic medication
Secondary Recurrence of SVT after one year follow-up 5 year
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