Actively Recruiting
Study of Ondansetron to Prevent Vasovagal Syncope in Adults A Randomized Phase 2 Trial with Double-Blind Placebo Control
Led by University of Calgary · Updated on 2024-05-10
70
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
About 20% of adults experience recurrent fainting, leading to significant symptoms, difficulties with work and driving, injuries, and reduced quality of life. Because few treatments have been proven effective in randomized trials, researchers are conducting a phase 2, randomized, double-blind study to test if blocking serotonin 5HT3 receptors with ondansetron can prevent fainting or near fainting caused by tilt-induced vasovagal syncope VVS. This study aims to provide preliminary data for future larger trials. Participants will be randomly assigned to receive either two doses of ondansetron 8 mg by mouth one the evening before and one the morning of the study or matching placebo doses on separate days. After dosing, participants undergo a tilt table test where their heart rhythm, blood pressure, and blood samples will be monitored continuously for up to 60 minutes or until fainting occurs. Additional measurements include bioelectrical impedance to assess fluid shifts in the body during posture changes and questionnaires to evaluate quality of life, anxiety, and depression. During the study, participants will have ECG electrodes and a blood pressure cuff applied, along with an intravenous line for blood sampling. Blood samples will be collected at baseline and during the tilt test to measure catecholamine levels. Participants will also complete online surveys assessing health-related quality of life and mood symptoms. The main outcome is the time until fainting or near fainting within one hour. Secondary outcomes include stroke volume, cardiac output, vascular resistance, and psychological measures monitored during the study and within 12 months. The study lasts about one day for the tilt test and includes follow-up assessments up to one year.
CONDITIONS
Brief Title
A Proof of Principle Study of Ondansetron for the Prevention of Vasovagal Syncope: The Eleventh Prevention of Syncope Trial (POST11)
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