POST 4
Research type
Research Study
Full title
ASSESSMENT OF MIDODRINE IN THE PREVENTION OF VASOVAGAL SYNCOPE: The Prevention of Syncope Trial IV (POST 4)
IRAS ID
109541
Contact name
Nicholas Gall
Contact email
Sponsor organisation
The University of Calgary
Eudract number
2015-000311-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a prospective, multicentre, randomized, double blind, parallel group CTIMP trial. About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials
This study will test the hypothesis that Midodrine prevents recurrences of vasovagal syncope (a form of fainting / unexplained black outs). Midodrine is a pro-drug whose active metabolite is effective in preventing orthostatic hypotension, which is a form of low blood pressure that happens when you stand up from sitting or lying down. Orthostatic hypotension can make you feel dizzy or lightheaded, and maybe even faint. Midodrine might therefore be effective in preventing vasovagal syncope.
A total of 128 patients (Internationally) with quantitative clinical diagnostic criteria for vasovagal syncope and at least 2 syncopal spells in the preceding year will be randomized to an initial dose of Midodrine 5 mg thrice daily or to a matching placebo and will be followed up over a 12 month observation period.
The primary outcome measure will be the time to the first syncope recurrence.
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/1553
Date of REC Opinion
26 Oct 2015
REC opinion
Further Information Favourable Opinion