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The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents

This study has been completed.
Sponsor:
Information provided by:
Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT00475462
First received: May 17, 2007
Last updated: May 18, 2007
Last verified: May 2007

May 17, 2007
May 18, 2007
July 2001
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Our primary outcome variable was recurrence of syncope. [ Time Frame: The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy ]
Same as current
Complete list of historical versions of study NCT00475462 on ClinicalTrials.gov Archive Site
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The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
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The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Syncope, Vasovagal
  • Drug: metoprolol
  • Drug: conventional treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2003
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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.
Both
6 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00475462
2004BA720A10
Yes
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Peking University First Hospital
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Study Director: Junbao DU, M.D. Peking University First Hospital
Peking University First Hospital
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP