Phase 4 N=210 Randomized Quadruple-blind Treatment

Clinical Trial for the Prevention of Vasovagal Syncope

Syncope, Vasovagal, Neurally-Mediated

Bottom Line

View on ClinicalTrials.gov: NCT00118482 ↗

Enrolled (actual)

210

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period. — 42; 54 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: fludrocortisone acetate (Drug)
Age: Pediatric, Adult, Older Adult · 14+ yrs
Sex: All
Sponsor: University of Calgary
Primary completion: Jul 2011

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00118482). 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.