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

Overview[ - collapse ][ - ]

Purpose The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.
ConditionSyncope, Vasovagal
InterventionDrug: metoprolol
Drug: conventional treatment
PhaseN/A
SponsorPeking University First Hospital
Responsible PartyPeking University First Hospital
ClinicalTrials.gov IdentifierNCT00475462
First ReceivedMay 17, 2007
Last UpdatedMay 18, 2007
Last verifiedMay 2007

Tracking Information[ + expand ][ + ]

First Received DateMay 17, 2007
Last Updated DateMay 18, 2007
Start DateJuly 2001
Estimated Primary Completion DateDecember 2003
Current Primary Outcome MeasuresOur primary outcome variable was recurrence of syncope. [Time Frame: The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleThe Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
Official TitleNot Provided
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 TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionSyncope, Vasovagal
InterventionDrug: metoprolol
Drug: conventional treatment
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment28
Estimated Completion DateDecember 2003
Estimated Primary Completion DateNot Provided
Eligibility 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.
GenderBoth
Ages6 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00475462
Other Study ID Numbers2004BA720A10
Has Data Monitoring CommitteeYes
Information Provided ByPeking University First Hospital
Study SponsorPeking University First Hospital
CollaboratorsNot Provided
Investigators Study Director: Junbao DU, M.D. Peking University First Hospital
Verification DateMay 2007