Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Vasovagal Syncope
In brief
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.
Key facts
- Study ID
- NCT01456481
- Run by
- Dr. Bob Sheldon
- People needed
- 134
- Starts
- 2011-11-01
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-05-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.