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

Syncope, Vasovagal Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475462
• Other study ID #: 2004BA720A10
• Status: Completed
• Phase: N/A
• First received: May 17, 2007
• Last updated: May 18, 2007
• Start date: July 2001
• Est. completion date: December 2003

Study information

• Verified date: May 2007
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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, ? to ? degrees of atrioventricular block, sinus bradycardia < 40 beats/min, or other contraindications for ß-blockers.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

Drug:
• metoprolol

• conventional treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our primary outcome variable was recurrence of syncope.		The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy