Syncope, Vasovagal Clinical Trial
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 |
The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2003 |
Est. primary completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital |
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 |
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