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Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV
Sponsor: Dr. Bob Sheldon
Summary
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.
Official title: Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (Post 4)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2011-11
Completion Date
2024-12-31
Last Updated
2024-05-09
Healthy Volunteers
No
Conditions
Interventions
midodrine hydrochloride
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.
matching placebo
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.
Locations (17)
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
Hamilton Health Sciences
Hamilton, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Hopital Sacre Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Prairie Vascular Research Network/Regina General Hospital
Regina, Saskatchewan, Canada
Saskatoon Cardiology Consultants/Royal University Hospital
Saskatoon, Saskatchewan, Canada
Medical University of Lodz
Lodz, Poland