Vasovagal syncope Signs and Symptoms Syncope
Conditions
Interventions
Double-blind, placebo-controlled trial of fludrocortisone.
Sponsors
University of Calgary (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children (greater than 13 years) and adults, either sex, with greater than two lifetime episodes of vasovagal syncope.
Exclusion criteria
Exclusion criteria: 1. Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome 2. An inability to give informed consent 3. Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia 4. Hypertrophic cardiomyopathy 5. A known intolerance to fludrocortisone 6. Another clinical need for fludrocortisone that can not be met with other drugs 7. A permanent pacemaker 8. A seizure disorder 9. A major chronic non-cardiovascular disease 10. Hypertension (blood pressure more than or equal to 130/85 on two occasions) or heart failure 11. Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m^2 according to the Cockroft-Gault formula) 12. Diabetes mellitus 13. Hepatic disease 14. Glaucoma 15. Any prior use of fludrocortisone acetate 16. A five-minute stand test resulting in diagnosis of postural orthostatic tachycardia syndrome or orthostatic hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first recurrence of syncope | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The frequency of syncope 2. Pre-syncope frequency duration and intensity 3. Quality of life | — |
Countries
Canada
Outcome results
None listed