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

INTERVENTION: 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 number: 50 mg BID‐100 mg BID Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: placebo Pharmaceutical Form: Tablet CONDITION: Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] Vasovagal Syncope PRIMARY OUTCOME: 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). Primary end point(s): The primary outcome event will be first recurrence of syncope 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). Timepoint(s) of evaluation of this end point: Patient will be followed up with in one week of syncopal event. SECONDARY OUTCOME: 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 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