Vasovagal Syncope
Conditions
Keywords
reflex fainting, vasovagal syncope, midodrine
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.
Interventions
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.
DRUGmatching 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.
Sponsors
Vanderbilt University
Dr. Bob Sheldon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the proportion of patients having at least one syncope recurrence. | 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| A secondary outcome will be the time between the first and second syncope recurrences. | 1 year |
| A secondary outcome will be the frequency of syncopal spells. | 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 outcomes will be quality of life as measured by the EQ-5D and the ISQL. | 1 year |
Countries
Canada, Poland, United States
Outcome results
None listed