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The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
This study has been completed.
Sponsored by: 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

MedlinePlus related topics: Fainting
Drug Information available for: Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Peking University First Hospital:

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

Enrollment: 28
Study Start Date: July 2001
Study Completion Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475462

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

Study ID Numbers: 2004BA720A10
Study First Received: May 17, 2007
Last Updated: May 18, 2007
ClinicalTrials.gov Identifier: NCT00475462  
Health Authority: China: Ministry of Health

Keywords provided by Peking University First Hospital:
Metoprolol and Syncope

Study placed in the following topic categories:
Signs and Symptoms
Unconsciousness
Metoprolol succinate
Consciousness Disorders
Neurologic Manifestations
Metoprolol
Neurobehavioral Manifestations
Syncope
Recurrence
Syncope, Vasovagal

Additional relevant MeSH terms:
Neurotransmitter Agents
Sympatholytics
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009