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Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia

NCT00390546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-12-13

Study results available
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Summary

This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context of SVT, yet both medications are used frequently.

Specific aims of the study:

To determine whether propranolol and digoxin differ in the:

1. Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or digoxin
2. Time to first recurrence of SVT in infants treated with propranolol or digoxin.
3. Incidence of adverse outcomes in infants treated with propranolol or digoxin.

Conditions

  • Supraventricular Tachycardia

Interventions

DRUG

Digoxin

DRUG

Propranolol

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Shubhayan Sanatani, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-08-31
Completion
2011-08-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00390546 on ClinicalTrials.gov