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

NCT00390546 | Completed Phase 3 Results

• 1 other identifier: H06-70156
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 14

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

Conditions

Supraventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode.

  6 months or until study endpoints were reached

Secondary Outcomes (2)

• Number of Treated Patients Experiencing First SVT Recurrence

  up to 110 days of treatment

• Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin

  12 months

Study Arms (2)

Propranolol

EXPERIMENTAL

Single dose of 0.5 mg/kg per dose and increased to 1.0 mg/kg per dose ITD for the second and subsequent doses.

Drug: Propranolol

Digoxin

EXPERIMENTAL

First 2 doses at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses

Drug: Digoxin

Interventions

Digoxin DRUG

Digoxin

Propranolol DRUG

Propranolol

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presentation with SVT due to AVRT or AVNRT.
• Age 4 months or less at presentation.
• No major structural heart disease (patent foramen ovale and patent ductus arteriosus are allowable.
• No other significant co-morbid condition likely to result in non-compliance or death in next 6 months.
• The SVT mechanism will be presumed to be AVRT or AVNRT if the ECG shows:
• Normal complex tachycardia with abrupt onset and offset;
• The RR interval remains relatively constant during tachycardia with heart rates of 220-310 bpm;
• VA (ventriculo-atrial) association \[i.e., there is a 1:1 AV relationship (except for cases of proven AV nodal reentry with a 2:1 relationship between atrium and ventricle)\]; and
• Termination of tachycardia with vagal maneuvres or adenosine with AV block or VA block.
• Additional supportive information:
• The presence of a P wave in either the ST segment or T wave, or the presence of a P wave altering the terminal portion of the QRS complex;
• Spontaneous termination of the tachycardia with a P wave;
• Onset with prolongation of the PR interval;
• Altered rate with resolution of temporary bundle branch block;
• Esophageal or electrophysiology study confirming tachycardia mechanism.

You may not qualify if:

• Failure to obtain consent;
• Known hypersensitivity to either study medication or suspension;
• Structural heart disease other than a patent foramen ovale or patent ductus arteriosus;
• Persistent abnormal cardiac function documented by echocardiogram (shortening fraction \<28%) in sinus rhythm;
• Pre-excitation (Wolff Parkinson White syndrome);
• Permanent junctional reciprocating tachycardia;
• Ectopic atrial tachycardia;
• Atrial flutter;
• Sick sinus syndrome or significant bradycardia;
• Long QT syndrome;
• Digoxin \> 40 micrograms/kg total received within past 7 days
• Amiodarone \>50 milligrams/kg total received within past month
• Asthma or obstructive airway disease;
• Renal failure.

Sponsors & Collaborators

• University of British Columbia: lead
• The Hospital for Sick Children: collaborator
• University of Utah: collaborator

Study Sites (14)

University of Southern California - Children's Hospital of Los Angeles

Los Angeles, California, United States

Location

Children's Hospital of Orange County

Orange, California, United States

Location

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Nationwide Children's Hospital Ohio

Columbus, Ohio, United States

Location

Medical University of Charleston South Carolina

Charleston, South Carolina, United States

Location

Primary Children's Medical Centre

Salt Lake City, Utah, United States

Location

Norfolk Children's Hospital of the King's Daughter's

Norfolk, Virginia, United States

Location

Northwest Pediatric Cardiology

Spokane, Washington, United States

Location

Stollery children's Hospital

Edmonton, Alberta, Canada

Location

Sonia Franciosi

Vancouver, British Columbia, V6H3N1, Canada

Location

Hospital for Sick Kids

Toronto, Ontario, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 22962431 DERIVED

MeSH Terms

Conditions

Tachycardia, Supraventricular

Interventions

Digoxin; Propranolol

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Besides issues of recruitment, potential limitations of this study include the selected dosing for propranol, as a higher dosage is sometimes used, and the lack of dose titration before the 2-month visit, both of which could influence drug efficacy.

Results Point of Contact

• Title: Dr. Shubhayan Sanatani
• Organization: University of British Columbia

ssanatani@cw.bc.ca

604-875-2345

Study Officials

• Shubhayan Sanatani, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 20, 2006
• Study Start: October 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: December 13, 2017
• Results First Posted: August 22, 2013

Record last verified: 2017-11

Locations

CA (4); US (10)