Improving blood pressure control in children who faint

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 investigation aims to evaluate the effectiveness of specific counterpressure maneuvers, such as exaggerated sway and gluteal muscle clenching, in enhancing blood pressure and cardiovascular control in pediatric patients experiencing recurrent fainting episodes. The study will involve 35 participants aged 6-18 years, who will undergo a series of tests to measure cardiovascular responses to these maneuvers compared to standard recommendations. Data collected will include blood pressure, cerebral blood flow, and stroke volume, alongside participant demographics and medical history. The goal is to determine if these new maneuvers provide a significant improvement over traditional methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

We are looking for English speaking pediatric patients aged 6-18 years with a diagnosis of recurrent fainting (at least two episodes of fainting with loss of consciousness or near loss of consciousness in the last year) of a vasovagal origin or associated with the postural orthostatic tachycardia syndrome (POTS) (as determined by a paediatric cardiologist) to take part in this study.

Exclusion Criteria:

Those with a diagnosis of recurrent fainting accompanied by any of the following will not be eligible to take part:

Known history of:

* Suspected or confirmed cardiac arrhythmia (e.g., Wolff-Parkinson-White, Long QT)
* Traumatic head injury
* New presentation of a seizure disorder OR epilepsy recurrence
* Overdose or intoxication
* Structural heart disease
* Cardiovascular disease including hypertension, diabetes, or renal disease
* Hypoglycemia
* Physical and/or psychological disability that impact their ability to complete the tests

Female participants of childbearing age will be excluded if they are pregnant, or think they might be. Participants who are taking any cardiovascular acting medications, including treatment for cardiovascular disease, or medications for orthostatic syncope (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine) will be excluded from the study.

In order to reduce the likelihood of transmission of COVID-19, participants will only be eligible to participate in the study if they have received full immunisation against COVID-19 according to current Health Canada guidelines. Accordingly, participants will be asked to provide evidence of their vaccination status in order to take part in the study.

Where it's running

• Simon Fraser University
  Burnaby, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Victoria E Claydon, PhD — Simon Fraser University
• Study coordinator: Erin L Williams, BSc
• Email: erin_williams_2@sfu.ca
• Phone: 6048976372

Similar studies

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

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• STAND-UP: opening narrowed veins above the heart to help low blood pressure when standing

  This study will try a minimally invasive catheter procedure to open narrowed supracardiac veins and see if that improves dizziness, fainting, or low blood pressure in adults with orthostatic hypotension or orthostatic intolerance that hasn't improved with standard treatments.

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• How age, sex, and a handgrip affect heart–vessel communication during low blood pressure

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• New method for treating reflex syncope using cardioneuroablation

  This study is testing a new heart treatment called cardioneuroablation to see which of three methods works best for finding the right spots in the heart to help people with severe fainting spells.

  Recruiting Centre of Postgraduate Medical Education · Warsaw, Masovian Voivodeship · NCT06472102

• Treatment for reflex syncope using cardioneuroablation

  This study is testing if a new procedure called cardioneuroablation can help people with severe reflex syncope by improving their heart function and reducing fainting episodes.

  Recruiting Centre of Postgraduate Medical Education · Warsaw · NCT06458140

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.