Using Atomoxetine to Prevent Fainting Spells
A Randomized, Prospective, Placebo-Controlled, Crossover Study of Atomoxetine in the Prevention of Vasovagal Syncope (POST7)
This study is testing whether a daily medication called Atomoxetine can help adults who often faint feel better and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05159687 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Atomoxetine, a norepinephrine transporter inhibitor, in preventing vasovagal syncope, a condition that causes fainting spells. The study aims to enroll adults who have experienced recurrent syncope and meet specific eligibility criteria. Participants will be randomly assigned to receive either Atomoxetine or a placebo, with the goal of assessing improvements in their symptoms and overall quality of life. The trial seeks to provide a simple, once-daily medication option for patients who have limited treatment alternatives due to contraindications of existing therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced at least two episodes of vasovagal syncope in the past year.
Not a fit: Patients with other causes of syncope or those who have contraindications to Atomoxetine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from recurrent vasovagal syncope.
How similar studies have performed: Preliminary studies have shown promise for norepinephrine transport inhibitors like Atomoxetine in preventing vasovagal syncope, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Robert Sheldon
- Email: sheldon@ucalgary.ca
- Phone: 4032108510
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.