A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)

NCT05755737 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Calgary

Phase

Phase 2

Started

2023-06-01

Last updated

2024-05-10

Condition(s) studied

Vasovagal Syncope (VVS)Syncope

Investigational drug(s) / intervention(s)

Ondansetron →Placebo

Ondansetron: Serotonin antagonists (5-HT3 antagonists) (Carbazole Derivative)

Placebo: Matching placebo identical in appearance.

Study 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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: 1. other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome 2. an inability to give informed consent 3. important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia 4. hypertrophic cardiomyopathy 5. a permanent pacemaker 6. a seizure disorder 7. hypertension defined as \>160/90 mm Hg 8. pregnancy 9. lactating women 10. glaucoma 11. medications with known effects on BP 12. Known hypersensitivity to ondansetron and related medications 13. other factors which, in the investigator's opinion, would prevent the subject from completing the protocol.

Primary outcome measure(s)

Time to syncope or presyncope — 1 hour

Trial sites (1)

Facility	City	Region	Status
University of Calgary	Calgary	Alberta	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05755737 on ClinicalTrials.gov ↗ ← All trials in Canada