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

RecruitingPhase 2Ages 18 Years - 100 YearsAllUniversity of Calgary
NCT05755737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Ondansetron
  • Placebo
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Where

1 site
University of Calgary
Calgary, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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