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Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia
This study is currently recruiting participants.
Verified by University of British Columbia, May 2008
Sponsors and Collaborators: University of British Columbia
The Hospital for Sick Children
University of Utah
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00390546
  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:

  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.

Condition Intervention Phase
Supraventricular Tachycardia in Infants
Drug: digoxin and propranolol
Phase III

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
Drug Information available for: Propranolol Dexpropranolol Propranolol hydrochloride Digoxin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment, Bio-equivalence Study
Official Title: Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia

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 ]

Estimated Enrollment: 220
Study Start Date: October 2006
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 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:

  1. Presentation with SVT due to AVRT or AVNRT.
  2. Age 4 months or less at presentation.
  3. No major structural heart disease (patent foramen ovale and patent ductus arteriosus are allowable.
  4. 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:

  1. Failure to obtain consent;
  2. Known hypersensitivity to either study medication or suspension;
  3. Structural heart disease other than a patent foramen ovale or patent ductus arteriosus;
  4. Persistent abnormal cardiac function documented by echocardiogram (shortening fraction <28%) in sinus rhythm;
  5. Pre-excitation (Wolff Parkinson White syndrome);
  6. Permanent junctional reciprocating tachycardia;
  7. Ectopic atrial tachycardia;
  8. Atrial flutter;
  9. Sick sinus syndrome or significant bradycardia;
  10. Long QT syndrome;
  11. Digoxin > 40 micrograms/kg total received within past 7 days
  12. Amiodarone >50 milligrams/kg total received within past month
  13. Asthma or obstructive airway disease;
  14. Renal failure.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390546

Contacts
Contact: Karen Gibbs, RN 604-875-2345 ext 7955 kgibbs@cw.bc.ca

Locations
United States, California
University of Southern California - Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States
Contact: Yaniv Bar-Cohen, MD     323-644-8637     YBarCohen@chia.usc.edu    
Principal Investigator: Yaniv Bar-Cohen, MD            
Children's Hospital of Orange County Recruiting
Orange, California, United States
Contact: Anjan Batra, MD     714-221-5500     abatra@choc.org    
Principal Investigator: Anjan Batra, MD            
United States, Iowa
Children's Hospital of Iowa City Recruiting
Iowa City, Iowa, United States
Contact: Ian Law, MD     319-356-4697     ian-law@uiowa.edu    
Principal Investigator: Ian Law, MD            
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Macdonald Dick, MD     734-936-9703     mdick@med.umich.edu    
Principal Investigator: Macdonald Dick, MD            
Children's Hospital of Detroit Recruiting
Detroit, Michigan, United States, 48201
Contact: H. Singh, MD     313-745-0154     hsingh6@dmc.org    
Principal Investigator: H. Singh, MD            
United States, Missouri
The Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Svjetlana Tisma-Dupanovic, MD         stisma@gmail.com    
Principal Investigator: Svjetlana Tisma-Dupanovic, MD            
United States, New York
Schneider Children's Hospital Recruiting
New Hyde Park, New York, United States
Contact: Andrew Blaufox, MD     718-470-7350     ablaufox@hshs.edu    
Principal Investigator: Andrew Blaufox, MD            
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States
Contact: Ron Kanter, MD     919-681-2916     kante001@mc.duke.edu    
Principal Investigator: Ron Kanter, MD            
United States, Ohio
Nationwide Children's Hospital Ohio Recruiting
Columbus, Ohio, United States
Contact: David Chan, MD     614-722-2530     rop@pediatrics.ohio-state.edu    
Principal Investigator: David Chan, MD            
United States, Oregon
Portland Oregon Health & Science University Recruiting
Portland, Oregon, United States
Contact: Seshadri Balaji, MD     503-494-2192     balajis@ohsu.edu    
Principal Investigator: Seshadri Balaji, MD            
United States, South Carolina
Medical University of Charleston South Carolina Recruiting
Charleston, South Carolina, United States
Contact: Philip Saul, MD     843-792-3287     saulp@musc.edu    
Principal Investigator: Philip Saul, MD            
United States, Utah
Primary Children's Medical Centre Recruiting
Salt Lake City, Utah, United States
Contact: Susan Etheridge, MD     801-588-2639     susan.etheridge@ihc.com    
Principal Investigator: Susan Etheridge, MD            
United States, Virginia
Norfolk Children's Hospital of the King's Daughter's Recruiting
Norfolk, Virginia, United States
Contact: Bert Ross, MD     757-668-7587     RossBA@@chkd.org    
Principal Investigator: Bert Ross, MD            
United States, Washington
Northwest Pediatric Cardiology Recruiting
Spokane, Washington, United States
Contact: Chris Anderson, MD     509-747-6707     DrA@nwkidshearts.com    
Principal Investigator: Chris Anderson, MD            
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53705
Contact: Kathleen Maginot, MD     608-263-9005     krmaginot@wisc.edu    
Principal Investigator: Kathleen Maginot, MD            
Canada, British Columbia
Children's Heart Centre, British Columbia's Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H3V4
Contact: Karen Gibbs     604 875-2345 ext 7955        
Principal Investigator: Shubhayan Sanatani, MD            
Canada, Ontario
Hospital for Sick Kids Recruiting
Toronto, Ontario, Canada
Contact: Elizabeth Stephenson, MD     416-813-6142     elizabeth.stephenson@sickkids.ca    
Principal Investigator: Elizabeth Stephenson, MD            
Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Anne Fournier, MD     514-345-4931     anne_fournier@ssss.gouv.gc.ca    
Principal Investigator: Anne Fournier, MD            
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

Responsible Party: University of British Columbia ( Dr. Shubhayan Sanatani )
Study ID Numbers: C06-0156, PG # 20R20051, ORSIL# 40-415
Study First Received: October 18, 2006
Last Updated: May 26, 2008
ClinicalTrials.gov Identifier: NCT00390546  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Tachycardia, Supraventricular
Heart Diseases
Propranolol
Tachycardia
Digoxin
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 15, 2009