Actively Recruiting
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
Led by University of Calgary · Updated on 2024-05-10
70
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, can be injured, and have poor quality of life. There are few therapies that have withstood the test of randomized clinical trials. the investigators will conduct a prospective, randomized, parallel, double-blind, proof-of-concept study that tests the hypothesis that serotonin 5HT3 receptor inhibition with ondansetron prevents tilt-induced vasovagal syncope (VVS) and pre-syncope in patients with clinical VVS. A total of 70 patients with quantitative clinical diagnostic criteria for VVS and at least 1 syncopal spell in the preceding year will be randomized in a double-blind acute phase 2 study to ondansetron 8 mg PO BID x 2 doses or matching placebo. The endpoint will be presyncope or syncope associated with diagnostic hemodynamic changes. These data should provide useful preliminary data as a foundation on which to conduct a subsequent randomized clinical trial.
CONDITIONS
Official Title
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 1 fainting spell in the year before enrollment
- A score of 2 or higher on the Calgary Syncope Symptom Score confirming vasovagal syncope
- Age 18 years or older with ability to give informed consent
You will not qualify if you...
- Other causes of fainting like ventricular tachycardia, complete heart block, orthostatic hypotension, or carotid sinus syndrome
- Unable to give informed consent
- Significant heart valve, coronary, muscle, conduction problems or serious arrhythmia
- Hypertrophic cardiomyopathy
- Having a permanent pacemaker
- History of seizures
- High blood pressure above 160/90 mm Hg
- Pregnancy
- Breastfeeding
- Glaucoma
- Taking medications known to affect blood pressure
- Known allergy to ondansetron or similar drugs
- Any other condition that the investigator feels would prevent completing the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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