Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia
This study has been completed.
Sponsor:
University of British Columbia
Collaborators:
The Hospital for Sick Children
University of Utah
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00390546
First received: October 18, 2006
Last updated: October 13, 2011
Last verified: October 2011
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Purpose
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:
- Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or digoxin
- Time to first recurrence of SVT in infants treated with propranolol or digoxin.
- Incidence of adverse outcomes in infants treated with propranolol or digoxin.
| Condition | Intervention | Phase |
|---|---|---|
|
Supraventricular Tachycardia in Infants |
Drug: digoxin and propranolol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- The primary endpoint of the study is the first episode of recurrent supraventricular tachycardia (SVT) requiring medical intervention to terminate the episode, [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary outcomes are Unblinding, loss-to follow-up, change or excatlation of medical therapy for SVT or death. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | October 2006 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: digoxin and propranolol
See Detailed Description.
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 4 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390546
Locations
| United States, California | |
| University of Southern California - Children's Hospital of Los Angeles | |
| Los Angeles, California, United States | |
| Children's Hospital of Orange County | |
| Orange, California, United States | |
| United States, Missouri | |
| The Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New York | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| United States, Ohio | |
| Nationwide Children's Hospital Ohio | |
| Columbus, Ohio, United States | |
| United States, South Carolina | |
| Medical University of Charleston South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Utah | |
| Primary Children's Medical Centre | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Norfolk Children's Hospital of the King's Daughter's | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| Northwest Pediatric Cardiology | |
| Spokane, Washington, United States | |
| Canada, Alberta | |
| Stollery children's Hospital | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Children's Heart Centre, British Columbia's Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H3V4 | |
| Canada, Ontario | |
| Hospital for Sick Kids | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| CHU Sainte-Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
Sponsors and Collaborators
University of British Columbia
The Hospital for Sick Children
University of Utah
Investigators
| Principal Investigator: | Shubhayan Sanatani, MD | University of British Columbia |
More Information
No publications provided by University of British Columbia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00390546 History of Changes |
| Other Study ID Numbers: | H06-70156, PG # 20R20051 |
| Study First Received: | October 18, 2006 |
| Last Updated: | October 13, 2011 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Supraventricular Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Anti-Arrhythmia Agents Propranolol Digoxin Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents Cardiotonic Agents Enzyme Inhibitors Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013