Status:
ACTIVE_NOT_RECRUITING
Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV
Lead Sponsor:
Dr. Bob Sheldon
Collaborating Sponsors:
Vanderbilt University
Conditions:
Vasovagal Syncope
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 withsto...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT01456481
Start Date
November 1 2011
End Date
December 31 2024
Last Update
May 9 2024
Active Locations (17)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
Vanderbilt University
Nashville, Tennessee, United States, 37232
3
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
4
Alberta Health Services - Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9