RecruitingNot Applicable

CAlgary SAlt for POTS

Canada50 participantsStarted 2024-05-07

Plain-language summary

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. Despite this recommendation, there is no long term data evaluating the use of salt in POTS. This randomized, placebo-controlled cross-over trial will evaluate a high salt diet, compared to a normal salt diet over a period of 3 months. Participants will complete 3 in lab evaluations including autonomic function testing, tilt table testing, blood volume and urine sodium evaluation, plasma catecholamine measurements and and cytokine measurements.

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 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 Exclusion Criteria: * 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

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

Upright Heart Rate

Timeframe: 10 Minutes

Trial details

NCT IDNCT05924646

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Satish R Raj, MD MSCI

4032106152 autonomic.research@ucalgary.ca

View on ClinicalTrials.gov More Postural Orthostatic Tachycardia Syndrome trials