Study of Atomoxetine in the Prevention of Vasovagal Syncope

Launched by UNIVERSITY OF CALGARY · Dec 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called atomoxetine can help prevent fainting spells known as vasovagal syncope (VVS). VVS can be a significant problem for many people, causing them to faint repeatedly and affecting their quality of life. Atomoxetine is already approved for treating attention deficit disorder and may help reduce the frequency of fainting in people with VVS. The trial will involve adults who have experienced at least two fainting episodes in the past year and will compare the effects of atomoxetine to a placebo, which is a pill that looks the same but contains no active medication. Participants will take the medication or placebo for six months, and researchers will track how many fainting episodes occur during that time.

To be eligible for this study, participants must be at least 18 years old and meet specific criteria related to their fainting episodes. They should not have other medical conditions that could explain their fainting, and certain medications and health issues may exclude them from participating. Throughout the study, participants can expect regular check-ins to monitor their health and well-being, as well as assessments of their quality of life and anxiety levels. If successful, the trial could lead to a new treatment option for those struggling with recurrent fainting spells, ultimately improving their daily lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Syncope according to the American College of Cardiology Guidelines 2017
• • 2. At least 2 vasovagal syncope spells in the preceding 12 months
• • 3. At least -2 on the Syncope Symptom Score for Structurally Normal Hearts
• • 4. At least 18 years old with informed consent
• 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 β-blocker, bupropion, α1-adrenergic agonists or antagonists, tricyclic antidepressants, serotonin reuptake inhibitors, scopolamine, theophylline, or fludrocortisone.