High Salt Diet for POTS
(CASA-POTS Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using fludrocortisone or have received IV saline in the last 2 months.
What data supports the effectiveness of the drug Sodium Chloride Capsules for POTS?
Is a high salt diet generally safe for humans?
Research suggests that while high salt intake can increase blood pressure, it does not necessarily jeopardize blood pressure control in patients already on antihypertensive medication. However, high salt intake is associated with a higher risk of cardiovascular disease, so it should be consumed in moderation.16789
How does the drug Sodium Chloride Capsules differ from other treatments for POTS?
Sodium Chloride Capsules are unique for POTS as they involve increasing salt intake, which is contrary to typical advice for conditions like hypertension where reducing sodium is recommended. This approach aims to increase blood volume and improve symptoms, which is different from other treatments that might focus on heart rate or blood pressure control.15101112
What is the purpose of this trial?
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.
Research Team
Satish R Raj
Principal Investigator
University of Calgary
Eligibility Criteria
The trial is for Canadian residents aged 18-60 with POTS, who experience a rapid heartbeat upon standing but don't have a drop in blood pressure. Participants must be able to visit the Calgary Autonomic Research Clinic and should not have orthostatic hypotension.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Moderate Dietary Salt Plus Additional Salt
Participants receive a moderate dietary salt plus additional salt diet for 6 weeks, including autonomic function testing and blood volume assessment
Treatment - Moderate Dietary Salt Alone (Placebo)
Participants receive a moderate dietary salt alone diet for 6 weeks, including autonomic function testing and blood volume assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Sodium Chloride Capsules
Sodium Chloride Capsules is already approved in Canada, United States, European Union for the following indications:
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Vasovagal Syncope (VVS)
- Postural Orthostatic Tachycardia Syndrome (POTS)
- Vasovagal Syncope (VVS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor