Prevention of Syncope (fainting) Trial 7
Summary
About 20% of adults faint regularly. No treatments are proven useful in executed clinical trials. This is a study to test the theory that Atomoxetine reduces the time to a recurrence of faint in patients who have a high likelihood of recurrent fainting. In this study half the patients will receive Atomoxetine in the first 6 months of the study then you will be swapped to an inactive pill called a placebo in the next 6 months or you will be taking the Placebo in the first 6 months of the study, and then you will be swapped over to Atomoxetine in the next 6 months. We will follow patients for a year.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 99
Inclusion criteria:
1. ≥2 faints in the year preceding enrolment
2. Vasovagal Syncope
3. Age ≥ 18 years
Exclusion criteria:
1. Other cause of syncope
2. A 5-minute stand test resulting in the diagnosis Orthostatic Hypotension or Postural Orthostatic Tachycardia Syndrome
3. An inability to give informed consent
4. Pregnant
5. Unwilling or unable to use adequate birth control while on study drug.
6. An important valvular, coronary, myocardial, or conduction abnormality, or significant arrhythmia
7. Uncontrolled hypertension
8. Uncontrolled hyperthyroidism
9. A permanent pacemaker
10. Taking or has recently taken a monoamine oxidase inhibitor
11. Pheochromocytoma
12. Glaucoma
13. Prior use of atomoxetine for syncope
14. Clinical need for atomoxetine or another potent norepinephrine transporter inhibitors (Ki NET < Ki SERT, Ki NET > 10 Ki atomoxetine),
15. Current use of the following medication: β-blocker, bupropion, α1-adrenergic agonists or antagonists, tricyclic antidepressants, serotonin reuptake inhibitors, scopolamine, theophylline, or fludrocortisone.
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Additional information
Contact information
Rasha Hamzeh Email: rasha.hamzeh1@ucalgary.ca Phone number:403-220-8897
Principal investigator:
Robert Stanley Sheldon
Clinical trial:
Yes
REB-ID:
REB21-1755