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| Sponsor: | University of British Columbia |
|---|---|
| Collaborators: |
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:
| Condition | Intervention | Phase |
|---|---|---|
|
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) |
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| 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 |
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 History of Changes |
| Health Authority: | Canada: Health Canada |
|
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 |