Using Atomoxetine to Prevent Fainting Spells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting

Study contacts

• Study coordinator: Robert Sheldon
• Email: sheldon@ucalgary.ca
• Phone: 4032108510

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for patients with recurrent vasovagal syncope and bradyarrhythmias

  This study is tracking how well different treatments work for people under 60 who have ongoing fainting spells and slow heart rates that don't get better with usual care.

  Recruiting Rush University Medical Center · Chicago, Illinois · NCT06166277

• Investigating how carbonated water affects blood pressure when standing

  This study is testing if drinking carbonated water can help healthy people maintain their blood pressure better when standing up.

  Recruiting Simon Fraser University · Burnaby, British Columbia · NCT05621460

• Assessing how heart rate affects blood flow in patients with pacemakers

  This study tests how changing heart rates affect blood flow in patients with pacemakers to see if it helps manage fainting spells.

  Recruiting University of Calgary · Calgary, Alberta · NCT03446326

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.