Assessment of Metoprolol in the Prevention of Vasovagal Syncope in Aging Subjects

• Conditions: Vasovagal Syncope; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-000284-14-GB
• Lead Sponsor: niversity of Calgary

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-28
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Patients will be eligible if they have:
(A) =1 syncopal spells in the year preceding enrolment
(B) =-2 points on the Calgary Syncope Symptom Score for Structurally Normal Hearts
(C) Age = 40 years.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Patients will be excluded if they have:
(1) resting heart rate <50 bpm or supine systolic blood pressure <90 mm Hg in the absence of beta blockers or antihypertensive medications
(2) other causes of syncope, such as sick sinus syndrome, ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome, (3) an inability to give informed consent
(4) important valvular, coronary, myocardial or conduction abnormality
(5) hypertrophic cardiomyopathy or known or probable genetic arrhythmia82, 83
(6) a contraindication to beta blockers such as asthma, insulin-dependent diabetes, severe depression, peripheral vascular disease, chronic obstructive pulmonary disease, or previous intolerance of beta blockers
(7) another clinical need for beta blockers which can not be met with other drugs
(8) a seizure disorder
(9) major chronic non-cardiovascular disease
(10) known hypersensitivity to metoprolol and derivatives
(11) an implanted defibrillator. Patients with pacemakers will be eligible provided that the pacemakers were not implanted for syncope.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified