Syncope, Vasovagal, Neurally-Mediated Clinical Trial
Official title:
A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)
The main question in the study is whether people taking fludrocortisone are less likely to
faint than people taking an inactive pill called a placebo.
Fludrocortisone is a drug that stimulates the body to retain salt and water. The
investigators know from some studies that it might prevent people from fainting at home and
in the community, while they are carrying on with their lives. There is some evidence that
salt and water retention help prevent fainting, but no one has a clear idea about whether
this is true. This study will try to determine if that is true.
About 10% of adults faint recurrently. These patients are often highly symptomatic, have
problems with employment and driving, and have well-documented reduced quality of life. There
are no therapies that have withstood the test of adequately conducted and credible randomized
clinical trials.
There is ample evidence of the importance of blood volume in the pathophysiology of vasovagal
syncope. Fludrocortisone acetate is a corticosteroid with a mild enhancement of
glucocorticoid activity and a marked increase in mineralocorticoid activity. It has no
appreciable glucocorticoid effect at doses between 0.05 to 0.2 mg, which are the commonly
used clinical doses for various disorders requiring mineralocorticoid adrenal replacement.
The acute actions of fludrocortisone acetate are sodium and water retention, at the expense
of urinary potassium excretion. Blood volume expansion with either dietary salt
supplementation or fludrocortisone is often recommended by clinicians for the treatment of
vasovagal syncope despite a paucity of good evidence for their efficacy. Four clinical
studies suggest its utility in the prevention of syncope. Fludrocortisone might decrease the
incidence of vasovagal syncope, but the quality of the evidence supporting its use is poor.
There are no randomized, placebo-controlled trials of fludrocortisone for the prevention of
vasovagal syncope. In this 5-year study the investigators will test the hypothesis that
fludrocortisone prevents recurrences of vasovagal syncope.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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