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Study of Atomoxetine in the Prevention of Vasovagal Syncope

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Calgary
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In plain words

What the trial is, and whether it could suit you

Project rationale: Vasovagal syncope (VVS) affects up to 50% of people, and recurrent syncope markedly reduces quality of life. We recently reported that it is frequently associated with injury and not surprisingly with clinical anxiety. Although conservative measures help many patients there remain many who require more care. CIHR-funded studies have shown that fludrocortisone and midodrine are effective but cannot be used in patients with contraindications such as hypertension and heart failure. Pacemakers are partially effective in older patients, but this is established only in the small minority with proven asystole. There remains a need for a simple, once-daily medication with few contraindications that can be used as first-line therapy for most patients with recurrent vasovagal syncope. Preliminary Studies: Norepinephrine transport (NET) inhibitors show promise as a novel treatme

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮฒ-blocker, bupropion, ฮฑ1-adrenergic agonists or antagonists, tricyclic antidepressants, serotonin reuptake inhibitors, scopolamine, theophylline, or fludrocortisone.
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What it tests

  • Atomoxetine Hydrochloride
  • Placebo
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Where

1 site
University of Calgary
Calgary, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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