Hypercapnia and Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome (NCT04271878) | Clinical Trial Compass
RecruitingNot Applicable
Hypercapnia and Orthostatic Tolerance in Postural Orthostatic Tachycardia Syndrome
Canada26 participantsStarted 2022-02-02
Plain-language summary
The mechanism behind postural orthostatic tachycardia syndrome (POTS) involves many causes including a sympathetic nervous system problem. Blood gases, like carbon dioxide (CO2), have an important effect on sympathetic activation.
The purpose of this research study is to determine if higher CO2 levels have any effect in lowering heart rate and reducing POTS symptoms when upright/standing. The investigators are also searching for the ideal CO2 concentration to achieve the most effective response
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Physician diagnosis of Postural Tachycardia Syndrome (POTS)
* Age 18-60 years
* Male and Female
* Non - smokers.
* Able and willing to provide informed consent.
* Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.
Exclusion Criteria:
* Overt cause for postural tachycardia, i.e., acute dehydration
* Participants with somatization or severe anxiety symptoms will be excluded
* Pregnant
* Inability to tolerate mask for the duration of the study
* Subjects who require portable oxygen at rest or with exercise
* Subjects with chronic heart failure or severe pulmonary disease who are unable to climb one flight of stairs due to shortness of breath.
* Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart Rate (HR) variation
Timeframe: difference between HR from supine to peak HR during tilt test for each intervention (mean value HR between the 8th and 9th minute of supine; peak parameters, during HUTT, mean value during the first min and between the 3rd and 8th min)