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| 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 |
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Supraventricular Tachycardia in Infants |
Drug: digoxin and propranolol |
Phase III |
| 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 |
| 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) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 4 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The SVT mechanism will be presumed to be AVRT or AVNRT if the ECG shows:
Additional supportive information:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Shubhayan Sanatani, MD | University of British Columbia |
More Information
| 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 |
|
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 |