Phase 4
Completed N=210
Clinical Trial for the Prevention of Vasovagal Syncope
Syncope, Vasovagal, Neurally-Mediated
Source: ClinicalTrials.gov NCT00118482 ↗
Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period. — 42; 54 Participants
◆ Published Evidence
Highly cited
151citations · ~15 / year
Fludrocortisone for the Prevention of Vasovagal Syncope: A Randomized, Placebo-Controlled Trial.
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.
Linked Publications (3)
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Fludrocortisone for the Prevention of Vasovagal Syncope: A Randomized, Placebo-Controlled Trial.
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The Second Prevention of Syncope Trial (POST II)--a randomized clinical trial of fludrocortisone for the prevention of neurally mediated syncope: rationale and study design.
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Prospective Assessment of the Risk of Vasovagal Syncope During Driving.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period. |
42; 54 | — |
| SECONDARY The Frequency of Syncope Will be the First Secondary Outcome Measure. |
44.0; 60.5 | — |
| SECONDARY Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score. |
— | — |
| SECONDARY Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients. |
69; 84 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00118482) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.