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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
Peking University First Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syncope, Vasovagal focused on measuring Metoprolol and Syncope

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 17, 2007
    Last Updated
    May 18, 2007
    Sponsor
    Peking University First Hospital
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    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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