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Europace 2003 5(1):71-75; doi:10.1053/eupc.2002.0284
© 2003 by European Society of Cardiology
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Prevention of Syncope Trial (POST): a randomized clinical trial of beta blockers in the prevention of vasovagal syncope

Rationale and study design

R. Sheldon1, S. Rose1, S. Connolly2 on behalf of the POST investigators3

1Cardiovascular Research Group, University of Calgary Calgary, Alberta, Canada; 2McMaster University Hamilton, Ontario, Canada; 3The POST investigators are listed herein

BACKGROUND: Few therapies for vasovagal syncope have been proven effective. A large, placebo-controlled clinical trial of beta-blockers is needed.

STRUCTURE OF STUDY: The Prevention of Syncope Trial (POST) is a multicentre, randomized, placebo-controlled, study of metoprolol in the prevention of vasovagal syncope. The primary hypothesis is that beta-blockers will increase the time to the first recurrence of syncope when compared with placebo. Patients will be randomized 1:1 to receive metoprolol or placebo, and followed for 1 year. The primary endpoint is the time to first syncope recurrence, and secondary endpoints include syncope frequency, presyncope, and quality of life.

INCLUSION AND EXCLUSION CRITERIA: Patients are eligible if they have a positive tilt test and 3 syncopal spells preceding the tilt test. They are excluded if they have seizures or other causes of syncope; important heart disease; a contraindication to or need for beta blockers; a permanent pacemaker; a major noncardiovascular disease; or previous use of beta blockers at a dose greater than the equivalent of metoprolol 25 mg twice daily for the purpose of suppressing vasovagal syncope.

POWER CALCULATIONS: We assume a 40% risk of syncope in the control arm, an absolute reduction of 20% by metoprolol, and a dropout of 20%. Entry of 220 patients will result in an 80% chance of reaching a positive conclusion about beta-blocker therapy with 2p=0·05.

Key Words: Vasovagal syncope, tilt table test, randomized clinical trial, quality of life, beta-blockers

Correspondence: Dr Robert Sheldon, University of Calgary, Health Sciences Centre, 3330 Hospital Drive NW, Calgary, Alberta T2N 4N1, Canada. Tel.: (403) 220-8191; Fax: (403) 270-0313; E-mail: sheldon{at}ucalgary.ca


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