Shortening Duration of Antiarrhythmic Medication for SVT in Infants

September 28, 2021 updated by: Tampere University Hospital
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Central Finland
      • Jyväskylä, Central Finland, Finland, 40620
        • Recruiting
        • Central Finland Central Hospital
        • Contact:
          • Ole Andersen, MD
    • Central Ostrobothnia
      • Kokkola, Central Ostrobothnia, Finland, 67200
        • Recruiting
        • Kokkola Central Hopsital
        • Contact:
          • Minna Rahkonen, MD
        • Contact:
          • Krista Björkman, MD
    • Kainuu
      • Kajaani, Kainuu, Finland, 87300
        • Not yet recruiting
        • Kajaani Central Hospital
        • Contact:
          • Jenny Karjalainen, MD
    • Kanta-Häme
      • Hämeenlinna, Kanta-Häme, Finland, 13530
        • Recruiting
        • Hämeenlinna Central Hospital
        • Contact:
          • Riikka Turunen, MD
    • Lapland
      • Rovaniemi, Lapland, Finland, 96101
        • Not yet recruiting
        • Lapland Central Hospital
        • Contact:
          • Linda Rautiainen, MD
    • North Karelia
      • Joensuu, North Karelia, Finland, 80210
        • Not yet recruiting
        • North Karelia Central Hospital
        • Contact:
          • Seppo Juuti, MD
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
    • North Savo
      • Kuopio, North Savo, Finland, 70029
    • Ostrobothnia
      • Vaasa, Ostrobothnia, Finland, 65130
        • Recruiting
        • Vaasa Central Hospital
        • Contact:
          • Johanna Uunila, MD
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampere University Hospital
        • Contact:
        • Contact:
          • Kaisa Ylänen, MD
        • Principal Investigator:
          • Tuija Poutanen, MD
    • Päijät-Häme
      • Lahti, Päijät-Häme, Finland, 15850
        • Not yet recruiting
        • Lahti Central Hospital
        • Contact:
          • Mikko Lavonius, MD
    • Region Of Kymenlaakso
      • Kotka, Region Of Kymenlaakso, Finland, 48210
        • Not yet recruiting
        • Kymenlaakso Central Hospital
        • Contact:
          • Ville Westerlund, MD
    • Satakunta
      • Pori, Satakunta, Finland, 28500
        • Not yet recruiting
        • Sakunta Central Hospital
        • Contact:
          • Johannes Nieminen, MD
    • South Karelia
      • Lappeenranta, South Karelia, Finland, 53130
        • Not yet recruiting
        • South Karelia Central Hospital
        • Contact:
          • Krista Ahtiainen, MD
    • South Ostrobothnia
      • Seinäjoki, South Ostrobothnia, Finland, 60220
        • Recruiting
        • Seinajoki Central Hospital
        • Contact:
          • Kirsi Nuolivirta, MD
    • South Savo
      • Mikkeli, South Savo, Finland, 50100
        • Recruiting
        • Mikkeli Central Hospital
        • Contact:
          • Lotta Mäkelä, MD
    • Southwest
      • Turku, Southwest, Finland, 20521
    • Uusimaa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of SVT after antiarrhythmic medication
Time Frame: 1 year follow-up
1 year follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with treatment failure
Time Frame: 4 months of antiarrhythmic medication
4 months of antiarrhythmic medication
Prevalence of adverse events
Time Frame: 4 months of antiarrhythmic medication
4 months of antiarrhythmic medication
Recurrence of SVT after one year follow-up
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Kuopio University Hospital

Investigators

  • Principal Investigator: Tuija Poutanen, MD, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R20113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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