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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2003-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Syncope, Vasovagal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

metoprolol

Intervention Type DRUG

conventional treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Junbao DU, M.D.

Role: STUDY_DIRECTOR

Peking University First Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004BA720A10

Identifier Type: -

Identifier Source: org_study_id