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

This study has been completed.
Sponsor:
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: September 6, 2013
Last verified: September 2013
  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
Drug: Digoxin
Drug: Propranolol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel 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:
  • Incidence of Recurrent Supraventricular Tachycardia (SVT) Requiring Medical Intervention to Terminate the Episode. [ Time Frame: 6 months or until study endpoints were reached ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Treated Patients Experiencing First SVT Recurrence [ Time Frame: up to 110 days of treatment ] [ Designated as safety issue: No ]
    Infants treated with propranolol or digoxin

  • Incidence of Adverse Outcomes in Infants With Propranolol or Digoxin [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    In relation to the study drugs


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)
Arms Assigned Interventions
Experimental: Propranolol
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
N/A
Experimental: Digoxin
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
N/A

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received: October 18, 2006
Results First Received: March 11, 2013
Last Updated: September 6, 2013
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
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014