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Sponsors and Collaborators: |
University of British Columbia The Hospital for Sick Children University of Utah |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00390546 |
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 |
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Supraventricular Tachycardia in Infants |
Drug: digoxin and propranolol |
Phase III |
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 |
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) |
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:
Contact: Karen Gibbs, RN | 604-875-2345 ext 7955 | kgibbs@cw.bc.ca |
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 |
Principal Investigator: | Shubhayan Sanatani, MD | University of British Columbia |
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 History of Changes |
Health Authority: | Canada: Health Canada |
Tachycardia, Supraventricular Vasodilator Agents Neurotransmitter Agents Heart Diseases Adrenergic Agents Tachycardia Cardiovascular Agents |
Antihypertensive Agents Propranolol Digoxin Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Arrhythmias, Cardiac |
Tachycardia, Supraventricular Vasodilator Agents Neurotransmitter Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Adrenergic Agents Tachycardia Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Pathologic Processes Propranolol Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Cardiovascular Diseases Anti-Arrhythmia Agents Arrhythmias, Cardiac |