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. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. There is considerable lower level evidence that it might prevent vasovagal syncope. The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
134
Target dose is midodrine hydrochloride or placebo pills 10 mg three times a day for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
The target dose in this study is 10mg q4h x3 for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
University of Minnesota
Minneapolis, Minnesota, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Calgary
Calgary, Alberta, Canada
Alberta Health Services - Royal Alexandra Hospital
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Red Deer Regional Hospital
Red Deer, Alberta, Canada
Victoria Cardiac Arrythmia Trials
Victoria, British Columbia, Canada
St. Boniface General Hospital
St. Boniface, Manitoba, Canada
New Brunswick Heart Centre
Saint John, New Brunswick, Canada
Queen E II Health Sciences Centre
Halifax, Nova Scotia, Canada
...and 7 more locations
The primary outcome measure will be the proportion of patients having at least one syncope recurrence.
Time frame: 1 year.
A secondary outcome will be the time between the first and second syncope recurrences.
Time frame: 1 year
A secondary outcome will be the frequency of syncopal spells.
Time frame: 1 year
A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).
Time frame: 1 year.
A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.
Time frame: 1 year
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