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Rationale for the prevention of syncope trial IV: assessment of midodrine.
- Source :
-
Clinical autonomic research : official journal of the Clinical Autonomic Research Society [Clin Auton Res] 2012 Dec; Vol. 22 (6), pp. 275-80. Date of Electronic Publication: 2012 May 19. - Publication Year :
- 2012
-
Abstract
- Background: Vasovagal syncope is a common problem associated with a poor quality of life, which improves when the frequency of syncope is reduced. Effective pharmacological therapies for vasovagal syncope have been elusive. Midodrine is a pro-drug whose primary metabolite is an alpha-1 adrenoreceptor agonist. A few studies have suggested that it may be beneficial in syncope, but all have had significant methodological limitations. A placebo-controlled clinical trial of midodrine for the prevention of vasovagal syncope is needed.<br />Structure of Study: The prevention of syncope trial IV (POST 4) is a multicenter, international, randomized, placebo-controlled study of midodrine in the prevention of vasovagal syncope. The primary end point is the time to first recurrence of syncope. Patients will be randomized 1:1 to receive midodrine 10-30 mg/day or matching placebo, and followed for 1 year. Secondary end points include syncope frequency, presyncope, and quality of life. Primary analysis will be performed with an intention-to-treat approach, with a secondary on-treatment analysis.<br />Power Calculations: A total sample size of 112, split equally between the two groups, achieves 85 % power to detect a 50 % relative risk reduction when the event rates are 55 and 27.5 % in the placebo and midodrine arms. Allowing for 20 % dropout, we propose to enroll 140 patients.<br />Registration: POST 4 is registered with http://www.clinicaltrials.gov (NCT01456481).<br />Implications: This study will be the first adequately powered trial to determine whether midodrine is effective in preventing vasovagal syncope. If it is effective, then midodrine may become the first-line pharmacological therapy for this condition.
- Subjects :
- Humans
Intention to Treat Analysis
Multicenter Studies as Topic
Prospective Studies
Research Design
Syncope, Vasovagal drug therapy
Treatment Outcome
Adrenergic alpha-1 Receptor Agonists therapeutic use
Midodrine therapeutic use
Randomized Controlled Trials as Topic methods
Syncope, Vasovagal prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1619-1560
- Volume :
- 22
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Clinical autonomic research : official journal of the Clinical Autonomic Research Society
- Publication Type :
- Academic Journal
- Accession number :
- 22610268
- Full Text :
- https://doi.org/10.1007/s10286-012-0167-5