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

Launched by UNIVERSITY OF CALGARY · Mar 2, 2023

Keywords

ClinConnect Summary

The POST11 trial is studying whether a medication called ondansetron can help prevent fainting episodes, known as vasovagal syncope (VVS), in adults who experience this condition. VVS can cause people to faint unexpectedly, which can lead to injuries and affect their daily lives, including work and driving. This study will involve around 70 participants who have had at least one fainting spell in the past year. Eligible participants must be at least 18 years old and be able to provide informed consent. Some individuals, such as those with certain heart conditions or who are pregnant, may not qualify for the study.

Participants in the trial will be randomly assigned to receive either ondansetron or a placebo (a pill with no active medication) for two doses. This means that neither the participants nor the researchers will know who is receiving which treatment during the study. The main goal is to see if ondansetron can effectively reduce the occurrence of fainting or near-fainting episodes when participants are put in a position that often triggers these events. The results from this trial will help researchers determine the next steps for developing treatments for people who struggle with VVS.

Gender

ALL

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:
• • 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.