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

Not Applicable

Completed

• Conditions: Syncope, Vasovagal

• Registration Number: NCT00475462
• Lead Sponsor: Peking University First Hospital

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.

Study Timeline

• Study Start: 2001-07
• Study Completion: 2003-12
• Status Verified: 2007-05
• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-18
• Last Update Submitted: 2007-05-18
• Study First Posted: 2007-05-21
• Last Update Posted: 2007-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Our primary outcome variable was recurrence of syncope.	The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy