Clinical Trial for the Prevention of Vasovagal Syncope (NCT00118482) | Clinical Trial Compass
CompletedPhase 4
Clinical Trial for the Prevention of Vasovagal Syncope
United States, Canada213 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period.