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

Syncope | Vasovagal Syncope (VVS)

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

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.

Lieu de l'étude

University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Robert S Sheldon, MD, PhD

[email protected]
403-220-8191
Étude parrainée par
University of Calgary
Participants recherchés
Plus d'informations
ID de l'étude: NCT05755737