Status:
RECRUITING
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
Lead Sponsor:
University of Calgary
Conditions:
Vasovagal Syncope (VVS)
Syncope
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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 th...
Detailed Description
This will be a randomized, double-blind, parallel-arm study in which the subjects will undergo a tilt table test following 2 doses of ondansetron 8 mg PO (evening before and morning of study) or after...
Eligibility Criteria
Inclusion Criteria:
(A) ≥1 syncopal spells in the year preceding enrolment (B) ≥-2 points on the Calgary Syncope Symptom Score( Accurate Calculation for Diagnosis of Vasovagal Syncope) (C) Age ≥18 years with informed consent
Exclusion Criteria:
- other causes of syncope, such as ventricular tachycardia, complete heart block, 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 permanent pacemaker
- a seizure disorder
- hypertension defined as >160/90 mm Hg
- pregnancy
- lactating women
- glaucoma
- medications with known effects on BP
- Known hypersensitivity to ondansetron and related medications
- other factors which, in the investigator's opinion, would prevent the subject from completing the protocol.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05755737
Start Date
June 1 2023
End Date
December 31 2026
Last Update
May 10 2024
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6