Status:
COMPLETED
Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
The Hospital for Sick Children
University of Utah
Conditions:
Supraventricular Tachycardia
Eligibility:
All Genders
Up to 4 years
Phase:
PHASE3
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 arrhythmi...
Detailed Description
The purpose of the proposed research is to conduct a randomized double-blind, multi-centre study of two antiarrhythmic medications, digoxin and propranolol, to evaluate whether one of these medication...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00390546
Start Date
October 1 2006
End Date
August 1 2011
Last Update
December 13 2017
Active Locations (14)
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1
University of Southern California - Children's Hospital of Los Angeles
Los Angeles, California, United States
2
Children's Hospital of Orange County
Orange, California, United States
3
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
4
Schneider Children's Hospital
New Hyde Park, New York, United States