Clinical Trial for the Prevention of Vasovagal Syncope

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Fludrocortisone

Criteria

Inclusion Criteria:

• Syncope as a cause of loss of consciousness according to European Society of Cardiology criteria

• > 2 lifetime syncopal spells preceding enrollment

• > or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts

• Age > 18 years with informed consent, or age > 14 years with consent and informed parental consent

Exclusion Criteria:

• Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) 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 known intolerance to fludrocortisone

• Another clinical need for fludrocortisone that cannot be met with other drugs

• A permanent pacemaker

• A seizure disorder

• A major chronic non cardiovascular disease

• Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure

• Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m2 according to the Cockroft-Gault formula)

• Diabetes mellitus

• Hepatic disease

• Glaucoma

• Any prior use of fludrocortisone acetate

• A 5-minute stand test resulting in diagnosis of postural orthostatic tachycardia syndrome or orthostatic hypotension