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New treatment option for Postural Orthostatic Tachycardia Syndrome
Official title CAlgary SAlt for POTS
ClinicalTrials.gov ID: NCT05924646
What this study is testing
- What it's testing
- Many patients with postural orthostatic tachycardia syndrome (POTS) have decreased plasma volume. Current POTS guidelines recommend \~10 g of salt and 2-3 L of fluid per day.
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Physician Diagnosis of POTS as defined by the CCS Consensus Statement and as follows:
- Sustained, excessive orthostatic tachycardia ≥ 30 bpm within 10 minutes standing.
- Absence of orthostatic hypotension (\>20/10 mmHg decrease) within 3 minutes standing.
- Chronic orthostatic symptoms that improve with recumbence.
- Age 18-60 years old.
You likely can't join if
- Overt cause for postural tachycardia (i.e., acute dehydration, thyroid disease)
- Participants with somatization or severe anxiety symptoms will be excluded
- Pregnant (self-reported)
- Underlying causes of tachycardia including acute hypovolemia, endocrinopathy, anemia, anxiety, medication effects, recreational drug effects, and...
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during...
- Fludrocortisone use (due to effects on renal Na+ handling)
See the full eligibility criteria
- Physician Diagnosis of POTS as defined by the CCS Consensus Statement and as follows:
- Sustained, excessive orthostatic tachycardia ≥ 30 bpm within 10 minutes standing.
- Absence of orthostatic hypotension (\>20/10 mmHg decrease) within 3 minutes standing.
- Chronic orthostatic symptoms that improve with recumbence.
- Age 18-60 years old.
- Ability to attend the Calgary Autonomic Research Clinic in Calgary.
- Resident of Canada
- Overt cause for postural tachycardia (i.e., acute dehydration, thyroid disease)
- Participants with somatization or severe anxiety symptoms will be excluded
- Pregnant (self-reported)
- Underlying causes of tachycardia including acute hypovolemia, endocrinopathy, anemia, anxiety, medication effects, recreational drug effects, and prolonged bedrest.
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
- Fludrocortisone use (due to effects on renal Na+ handling)
- Patients who have received IV saline in the 2 months preceding the study or who plan to receive it during the course of the study
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.