NCT00475462

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2001

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

May 17, 2007

Last Update Submit

May 18, 2007

Conditions

Syncope, Vasovagal

Keywords

Metoprolol and Syncope

Outcome Measures

Primary Outcomes (1)

  • Our primary outcome variable was recurrence of syncope.

    The primary endpoint was recurrence of syncope within 2 weeks after beginning therapy

Interventions

metoprololDRUG
conventional treatmentDRUG

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Syncope, VasovagalSyncope

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Junbao DU, M.D.

    Peking University First Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

July 1, 2001

Study Completion

December 1, 2003

Last Updated

May 21, 2007

Record last verified: 2007-05