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

Phase 3 Completed 72 enrolled University of British Columbia The Hospital for Sick Children · collab University of Utah · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2006-10
Primary completion: 2010-08
Completion: 2011-08

Outcome

Missed primary endpoint

paper SVT recurred in 19% of patients on digoxin and 31% of patients on propranolol (P=0.25). PMID 22962431 ↗

Publications

Sanatani S, Potts JE, Reed JH, Saul JP, Stephenson EA, Gibbs KA, Anderson CC, Mackie AS, Ro PS, Tisma-Dupanovic S, Kanter RJ, Batra AS, Fournier A, Blaufox AD, Singh HR, Ross BA, Wong KK, Bar-Cohen Y, McCrindle BW, Etheridge SP. The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants. Circ Arrhythm Electrophysiol. 2012 Oct;5(5):984-91. doi: 10.1161/CIRCEP.112.972620. Epub 2012 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Digoxin	Other / unclassified	0.0035 mg/kg	—
Subject	Propranolol	Small molecule	1 mg/kg	—

Indications

No indication recorded.