Status:
COMPLETED
Clinical Trial for the Prevention of Vasovagal Syncope
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Syncope, Vasovagal, Neurally-Mediated
Eligibility:
All Genders
14+ years
Phase:
PHASE4
Brief 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 bo...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00118482
Start Date
May 1 2005
End Date
July 1 2011
Last Update
October 15 2019
Active Locations (14)
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1
Boston University
Boston, Massachusetts, United States, 02118
2
Vanderbilt University
Nashville, Tennessee, United States, 37232-2195
3
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23225-3838
4
University of Calgary, Faculty of Medicine
Calgary, Alberta, Canada, T2N 4N1