CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
Digoxin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • Presentation with SVT due to AVRT or AVNRT
  • Age 4 months or less at presentation
  • No major structural heart disease (PFO and PDA allowable)
Key exclusion· 13
  • Structural heart disease other than PFO or PDA
  • Persistent abnormal cardiac function (shortening fraction <28%)
  • Pre-excitation (Wolff Parkinson White syndrome)
  • Permanent junctional reciprocating tachycardia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00390546
NCT00390546Phase 3Completed

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

University of British Columbia·interventional·Posted Oct 20, 2006·Updated Dec 13, 2017

In Brief

A Phase 3 clinical trial evaluating Digoxin and Propranolol for Supraventricular Tachycardia. Completed, enrolled 72 participants across 14 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2006
Enrollment StartOct 1, 2006
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.7 years ago

Interventions

Digoxindrug

Propranololdrug