POST 5

• Research type

  Research Study

• Full title

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

• IRAS ID

  145712

• Contact name

  Nicholas Gall

• Contact email

  nicholasgall@nhs.net

• Sponsor organisation

  University of Calgary

• Eudract number

  2015-000284-14

• Duration of Study in the UK

  4 years, 0 months, 1 days

• Research summary

  About 20% of adults faint recurrently1. Patients who faint repeatedly are highly symptomatic, have problems with employment and driving, and have reduced quality of life. There are no pharmacologic therapies that have withstood the test of adequately designed and conducted randomized clinical trials.

  We will test the hypothesis that metoprolol prevents recurrences of vasovagal syncope in patients at least 40 years old. A total of 248 patients with quantitative clinical diagnostic criteria for vasovagal syncope and at least 1 syncopal spell in the preceding year will be randomized to an initial dose of metoprolol 50 mg twice daily or to a matching placebo in a prospective, randomized, double blind, parallel group, with an observation period of 12 months. The primary outcome measure will be the time
  to the first syncope recurrence.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  15/LO/1554

• Date of REC Opinion

  26 Oct 2015

• REC opinion

  Further Information Favourable Opinion