RecruitingPHASE3INTERVENTIONAL

Study of Atomoxetine in the Prevention of Vasovagal Syncope

This research is investigating whether a medication called atomoxetine could be a helpful treatment for a common condition called vasovagal syncope. This condition causes people to faint regularly, which can affect their daily life and sometimes lead to injuries. While some treatments exist, many people still need effective options, especially those who cannot use current medications or pacemakers. Atomoxetine is already approved for ADHD and has shown promise in smaller studies for preventing fainting. This large study will compare atomoxetine to a dummy pill (placebo) to see if it can safely reduce fainting episodes, improve quality of life, and be a suitable first-line treatment for many patients in the UK.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Calgary

Enrolment target

180

Start

01 Jun 2022

Estimated completion

01 Sep 2027

Vasovagal Syncope

What is this study about?

Many people experience fainting spells due to a condition called vasovagal syncope (VVS). This happens when your body overreacts to certain triggers, causing your heart rate and blood pressure to drop suddenly, leading to a temporary loss of consciousness. For some, these fainting spells happen often, which can be upsetting, lead to injuries, and really impact their daily life and wellbeing.

While doctors have some ways to help, like suggesting lifestyle changes or prescribing certain medications, these don't work for everyone or might not be suitable for people with other health conditions. This means there's still a real need for a simple, safe, and effective treatment that many people with VVS can use.

This study is focusing on a medication called atomoxetine. It's already used to treat attention deficit disorder (ADHD), but early research suggests it might also help prevent fainting spells in people with VVS. We want to conduct a larger, more thorough study to see if atomoxetine can reduce how often people faint, improve their overall quality of life, and whether it could become a widely used treatment option for VVS.

Key takeaways

The study tests if atomoxetine can reduce fainting in vasovagal syncope.
It's a potential new treatment for a common, life-disrupting condition.
You'll get either atomoxetine or a dummy pill, then swap after 6 months.
The study lasts about a year and a half.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with vasovagal syncope – which means you've fainted at least twice in the past year due to this condition. You also need to have certain symptoms related to syncope, as determined by a special score your doctor will check.

There are several reasons why you might not be able to join. For example, if your fainting is caused by another health problem, or if you have certain heart conditions like uncontrolled high blood pressure or significant problems with your heart valves or rhythm. You also can't be pregnant, breastfeeding, or planning to become pregnant during the study. If you're already taking specific medicines that might interfere with the study drug, like certain beta-blockers or antidepressants, you wouldn't be able to participate. Lastly, if you've already taken atomoxetine for fainting in the past, or if you have certain eye conditions like glaucoma, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you fainted at least twice in the past year due to vasovagal syncope?
Do you have any significant heart conditions or uncontrolled high blood pressure?
Are you pregnant, breastfeeding, or planning to become pregnant?
Are you currently taking any specific medications that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned either the study drug, atomoxetine, or a dummy pill (placebo) for six months. After a one-week break, you'll then switch to the other treatment for another six months. During the study, neither you nor your study doctor will know which treatment you are receiving at any given time. Regularly, you will have check-ups, which may include physical examinations, questions about your symptoms, fainting episodes, and how you are feeling generally. We will also collect saliva samples to look at genetic factors. The total time you will be involved in the study will be about 12 and a half months.

Potential risks and benefits

Taking part in this study could potentially reduce your fainting spells and improve your quality of life. However, as with any medication, atomoxetine may have side effects. While atomoxetine is generally well-tolerated, potential side effects will be discussed in detail by the study team, and you will be closely monitored throughout the study. Remember, participating is entirely voluntary, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is vasovagal syncope?

It's a common condition where certain triggers cause your heart rate and blood pressure to drop suddenly, leading you to faint.

What is atomoxetine?

It's a medication currently used to treat ADHD, but we're studying if it can help prevent fainting in people with vasovagal syncope.

Will I know if I'm getting the real drug or a dummy pill?

No, neither you nor your study doctor will know which treatment you are receiving. This helps make the study fair and accurate.

How long will I be in the study?

You will be in the study for about 12 and a half months in total, including two six-month treatment periods and a short break in between.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Robert Sheldon

sheldon@ucalgary.ca 4032108510 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.