Clinical Trials Directory

Trials / Completed

CompletedNCT00475462

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Peking University First Hospital · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGmetoprolol
DRUGconventional treatment

Timeline

Start date
2001-07-01
Completion
2003-12-01
First posted
2007-05-21
Last updated
2007-05-21

Source: ClinicalTrials.gov record NCT00475462. Inclusion in this directory is not an endorsement.