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Trial record 3 of 42 for:    Syncope | Child

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00475462
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : May 21, 2007
Information provided by:
Peking University First Hospital

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.

Condition or disease Intervention/treatment Phase
Syncope, Vasovagal Drug: metoprolol Drug: conventional treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2001
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Primary Outcome Measures :
  1. Our primary outcome variable was recurrence of syncope. [ Time Frame: The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00475462

Sponsors and Collaborators
Peking University First Hospital
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Study Director: Junbao DU, M.D. Peking University First Hospital

Layout table for additonal information Identifier: NCT00475462     History of Changes
Other Study ID Numbers: 2004BA720A10
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007
Keywords provided by Peking University First Hospital:
Metoprolol and Syncope
Additional relevant MeSH terms:
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Syncope, Vasovagal
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
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