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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

other causes of syncope, such as ventricular tachycardia, complete heart block, orthostatic hypotension or hypersensitive carotid sinus syndrome

an inability to give informed consent

important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia

hypertrophic cardiomyopathy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ondansetron

    Drug

    Serotonin antagonists (5-HT3 antagonists) (Carbazole Derivative)

  • Placebo

    Drug

    Matching placebo identical in appearance.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: OndansetronActive comparator 1 intervention
Group B: PlaceboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to syncope or presyncope

Time frame
1 hour

Secondary outcomes

1

stroke volume

Time frame
1 hour
2

cardiac output

Heart Rate \* Stroke volume, and it will be measured using Beat -To Beat BP measurement and HR measurement

Time frame
1 hour
3

catecholamine levels

Time frame
1 hour
4

Hospital Anxiety and Depression Scale (HADS)

The total score is out of 42, (21 per subscale). Scores are derived by summing responses for each of the two subscales or for the scale as a whole Higher scores indicate greater levels of anxiety or depression. The total HADS score may be regarded as a global measure of psychological distress

Time frame
Within 12 months period of the study

Other outcomes

Sponsors and contacts

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