NCT Number: NCT00475462
The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.
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Conditions
Age range
6 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Conventional Treatment
DrugPrimary outcomes
-
Our primary outcome variable was recurrence of syncope.
Time frame: The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy
Sponsors and collaborators
Lead sponsor
Peking University First Hospital
Other
Registry information
Important dates
- Study start
- 2001
- Study completion
- 2003
- First posted
- May 21, 2007
- Registry last updated
- May 21, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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