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| Sponsor: | Peking University First Hospital |
|---|---|
| Information provided by: | Peking University First Hospital |
| ClinicalTrials.gov Identifier: | NCT00475462 |
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.
| Condition | Intervention |
|---|---|
|
Syncope, Vasovagal |
Drug: metoprolol Drug: conventional treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Enrollment: | 28 |
| Study Start Date: | July 2001 |
| Study Completion Date: | December 2003 |
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| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they had:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00475462 History of Changes |
| Other Study ID Numbers: | 2004BA720A10 |
| Study First Received: | May 17, 2007 |
| Last Updated: | May 18, 2007 |
| Health Authority: | China: Ministry of Health |
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Metoprolol and Syncope |
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Syncope Syncope, Vasovagal Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Metoprolol Metoprolol succinate Anti-Arrhythmia Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |