The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
Primary Purpose
Syncope, Vasovagal
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
metoprolol
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Syncope, Vasovagal focused on measuring Metoprolol and Syncope
Eligibility Criteria
Inclusion Criteria:
- Children with a history of syncope were included if they had had at least three syncopal episodes per year and had a positive head-up tilt test result.
Exclusion Criteria:
Patients were excluded if they had:
- Other causes of syncope;
- Cardiovascular and/or systemic disease;
- Systolic blood pressure >130 mm Hg or diastolic blood pressure >90 mm Hg; or
- History of asthma, impaired liver function, Ⅱ to Ⅲ degrees of atrioventricular block, sinus bradycardia < 40 beats/min, or other contraindications for β-blockers.
Sites / Locations
Outcomes
Primary Outcome Measures
Our primary outcome variable was recurrence of syncope.
Secondary Outcome Measures
Full Information
NCT ID
NCT00475462
First Posted
May 17, 2007
Last Updated
May 18, 2007
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00475462
Brief Title
The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University First Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.
Detailed Description
Syncope is often a frustrating clinical problem seen in pediatric patients. Most pediatric syncope is benign, and vasovagal syncope (VVS) is the most common type of syncope seen in children . The diagnosis of VVS is established by history, often confirmed by tilt tests. A wide range of drugs has been proposed for VVS , with β-adrenergic blocking agents being first-line therapy. However, clinical studies have shown conflicting results in terms of therapy effectiveness. β-blockers have been claimed to be effective for 60% to 100% of young patients in many uncontrolled studies but not in most short- and long-term controlled studies . Sheldon et al., in a recent multicenter, double-blinded, placebo-controlled, randomized study of adult patients, reported that metoprolol was not effective in preventing VVS. To our knowledge, no pediatric randomized controlled trials with long-term follow-up have demonstrated the efficacy of β-blockers for the prevention of syncope.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Metoprolol and Syncope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
metoprolol
Intervention Type
Drug
Intervention Name(s)
conventional treatment
Primary Outcome Measure Information:
Title
Our primary outcome variable was recurrence of syncope.
Time Frame
The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with a history of syncope were included if they had had at least three syncopal episodes per year and had a positive head-up tilt test result.
Exclusion Criteria:
Patients were excluded if they had:
Other causes of syncope;
Cardiovascular and/or systemic disease;
Systolic blood pressure >130 mm Hg or diastolic blood pressure >90 mm Hg; or
History of asthma, impaired liver function, Ⅱ to Ⅲ degrees of atrioventricular block, sinus bradycardia < 40 beats/min, or other contraindications for β-blockers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbao DU, M.D.
Organizational Affiliation
Peking University First Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
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