At a glance
ClinicalIndex Comparison Record- ✓Syncope as cause of loss of consciousness per European Society of Cardiology criteria
- ✓More than 2 lifetime syncopal spells before enrollment
- ✓Syncope Symptom Score for Structurally Normal Hearts ≥-2 points
- ✓Age >18 years with informed consent, or age >14 years with parental consent
- ✕Alternative syncope etiologies including ventricular tachycardia, complete heart block, postural/orthostatic hypotension, or carotid sinus syndrome
- ✕Significant valvular, coronary, myocardial, or conduction abnormality or arrhythmia
- ✕Hypertrophic cardiomyopathy
- ✕Known intolerance to fludrocortisone
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)
In Brief
A Phase 4 clinical trial evaluating fludrocortisone acetate for Syncope, Vasovagal, Neurally-Mediated. Completed, enrolled 213 participants across 14 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily