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.

Abstract

Background: Supraventricular tachycardia (SVT) is one of the most common conditions requiring emergent cardiac care in children, yet its management has never been subjected to a randomized controlled clinical trial. The purpose of this study was to compare the efficacy and safety of the 2 most commonly used medications for antiarrhythmic prophylaxis of SVT in infants: digoxin and propranolol.

Methods and results: This was a randomized, double-blind, multicenter study of infants <4 months with SVT (atrioventricular reciprocating tachycardia or atrioventricular nodal reentrant tachycardia), excluding Wolff-Parkinson-White, comparing digoxin with propranolol. The primary end point was recurrence of SVT requiring medical intervention. Time to recurrence and adverse events were secondary outcomes. Sixty-one patients completed the study, 27 randomized to digoxin and 34 to propranolol. SVT recurred in 19% of patients on digoxin and 31% of patients on propranolol (P=0.25). No first recurrence occurred after 110 days of treatment. The 6-month recurrence-free status was 79% for patients on digoxin and 67% for patients on propranolol (P=0.34), and there were no first recurrences in either group between 6 and 12 months. There were no deaths and no serious adverse events related to study medication.

Conclusions: There was no difference in SVT recurrence in infants treated with digoxin versus propranolol. The current standard practice may be treating infants longer than required and indicates the need for a placebo-controlled trial. Clinical Trial Registration Information- http://clinicaltrials.gov; NCT-00390546.

Trial registration: ClinicalTrials.gov NCT00390546.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-Arrhythmia Agents / therapeutic use*
  • Canada
  • Chi-Square Distribution
  • Digoxin / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Proportional Hazards Models
  • Propranolol / therapeutic use*
  • Recurrence
  • Tachycardia, Supraventricular / prevention & control*
  • Treatment Outcome
  • United States

Substances

  • Anti-Arrhythmia Agents
  • Digoxin
  • Propranolol

Associated data

  • ClinicalTrials.gov/NCT00390546