drugset / Trial / NCT01456481

Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV

NCT01456481

Phase 4 Unknown 134 enrolled Dr. Bob Sheldon Vanderbilt University · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2011-11
Primary completion
2018-12-20
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midodrine Small molecule 10 mg