Status:

RECRUITING

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

Lead Sponsor:

University of Calgary

Conditions:

Vasovagal Syncope (VVS)

Syncope

Eligibility:

All Genders

18-100 years

Phase:

PHASE2

Brief 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 th...

Detailed Description

This will be a randomized, double-blind, parallel-arm study in which the subjects will undergo a tilt table test following 2 doses of ondansetron 8 mg PO (evening before and morning of study) or after...

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.

Key Trial Info

Start Date :

June 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT05755737

Start Date

June 1 2023

End Date

December 31 2026

Last Update

May 10 2024

Active Locations (1)

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1

University of Calgary

Calgary, Alberta, Canada, T2N 4Z6