Vasovagal Syncope
Conditions
Interventions
Trade Name: Metoprolol
Product Name: Metoprolol tartrate
Pharmaceutical Form: Tablet
INN or Proposed INN: Metoprolol tartate
Concentration unit: mg milligram(s)
Concentration type: range
Concentration
Sponsors
University of Calgary
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Will Metoprolol reduces the time to a first recurrence of syncope(fainting) in patients =40 years old who have a high likelihood of recurrent vasovagal syncope( fainting). ;Secondary Objective: We will measure the frequency of syncopal spells; the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale); and quality of life as measured by the Euro Qol (EQ-5D) and the Impact of Syncope on Quality of Life (ISQL).;Primary end point(s): The primary outcome event will be first recurrence of syncope;Timepoint(s) of evaluation of this end point: Patient will be followed up with in one week of syncopal event. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Presyncope (Feeling like patient is about to faint) (2) Quality of Life measured by questionnaires ;Timepoint(s) of evaluation of this end point: (1) Presyncope (Feeling like patient is about to faint) - Recorded at all follow up visits over 1 year (2) Quality of Life measured by questionnaires - Measured at baseline, 6 months & 12 month follow up | — |
Countries
Canada, United Kingdom, United States
Contacts
Public ContactDr Nicholas Gall
King's College Hospital NHS Foundation Trust
Outcome results
None listed