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Sponsored by: |
Peking University First Hospital |
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Information provided by: | Peking University First Hospital |
ClinicalTrials.gov Identifier: | NCT00475462 |
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 |
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Syncope, Vasovagal |
Drug: metoprolol Drug: conventional treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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.
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:
Study ID Numbers: | 2004BA720A10 |
Study First Received: | May 17, 2007 |
Last Updated: | May 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00475462 History of Changes |
Health Authority: | China: Ministry of Health |
Metoprolol and Syncope |
Neurotransmitter Agents Unconsciousness Adrenergic Agents Consciousness Disorders Cardiovascular Agents Antihypertensive Agents Metoprolol Syncope Recurrence |
Syncope, Vasovagal Signs and Symptoms Metoprolol succinate Neurologic Manifestations Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents Neurobehavioral Manifestations |
Sympatholytics Neurotransmitter Agents Unconsciousness Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Consciousness Disorders Nervous System Diseases Cardiovascular Agents Antihypertensive Agents Metoprolol Syncope |
Pharmacologic Actions Syncope, Vasovagal Signs and Symptoms Autonomic Agents Therapeutic Uses Metoprolol succinate Neurologic Manifestations Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents Neurobehavioral Manifestations |