Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV
- Conditions
- Vasovagal Syncope
- Interventions
- Drug: matching placebo
- Registration Number
- NCT01456481
- Lead Sponsor
- Dr. Bob Sheldon
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 134
-
Patients will be eligible if they have:
- ≥2 syncopal spells in the year preceding enrolment, and
- ≥ -2 points on the Syncope Symptom Score for Structurally Normal hearts, and
- Age ≥ 18 years with informed consent.
-
Patients will be excluded if they have:
- other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome,
- an inability to give informed consent,
- important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia,
- hypertrophic cardiomyopathy,
- a permanent pacemaker,
- a seizure disorder,
- urinary retention,
- hypertension defined as >140/90 mm Hg,
- hepatic disease,
- glaucoma or
- a 5-minute stand test resulting in diagnoses of Postural Orthostatic Tachycardia Syndrome or Orthostatic Hypotension.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description midodrine hydrochloride pills midodrine hydrochloride - oral placebo or sugar pill midodrine hydrochloride - oral placebo or sugar pill matching placebo -
- Primary Outcome Measures
Name Time Method The primary outcome measure will be the proportion of patients having at least one syncope recurrence. 1 year.
- Secondary Outcome Measures
Name Time Method A secondary outcome will be the time between the first and second syncope recurrences. 1 year A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). 1 year. A secondary outcome will be the frequency of syncopal spells. 1 year A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. 1 year
Trial Locations
- Locations (17)
Saskatoon Cardiology Consultants/Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
Victoria Cardiac Arrythmia Trials
🇨🇦Victoria, British Columbia, Canada
New Brunswick Heart Centre
🇨🇦Saint John, New Brunswick, Canada
St. Boniface General Hospital
🇨🇦St. Boniface, Manitoba, Canada
Queen E II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Health Sciences
🇨🇦Hamilton, 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
Medical University of Lodz
🇵🇱Lodz, Poland
Red Deer Regional Hospital
🇨🇦Red Deer, Alberta, Canada
Alberta Health Services - Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada