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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ondansetron
DrugSerotonin antagonists (5-HT3 antagonists) (Carbazole Derivative)
Placebo
DrugMatching placebo identical in appearance.
Treatment groups
Trial outcomes
Primary outcomes
Time to syncope or presyncope
Secondary outcomes
stroke volume
cardiac output
Heart Rate \* Stroke volume, and it will be measured using Beat -To Beat BP measurement and HR measurement
catecholamine levels
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
Sponsors and contacts
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