The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
Information source: Peking University First Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Syncope, Vasovagal
Intervention: metoprolol (Drug); conventional treatment (Drug)
Phase: N/A
Status: Completed
Sponsored by: Peking University First Hospital Official(s) and/or principal investigator(s):
Junbao DU, M.D., Study Director, Affiliation: Peking University First Hospital
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Our primary outcome variable was recurrence of syncope.
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.
Eligibility
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: July 2001
Ending date: December 2003
Last updated: May 18, 2007
|
