CAlgary SAlt for POTS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Calgary
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Sodium Chloride Capsules
Dietary supplementTable salt in slow release capsules.
Microcystalline Cellulose Capsules
Other interventionMicrocrystalline Cellulose Capsules (Placebo)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Moderate Dietary Salt Plus Additional SaltExperimental treatment 1 intervention
Group B: Moderate Dietary Salt AlonePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Upright Heart Rate
Upright heart rate measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm
Time frame
10 MinutesSecondary outcomes
1
Vanderbilt Orthostatic Symptom Score (VOSS)
VOSS score measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm
Time frame
10 Minutes2
Systolic Blood Pressure
Upright systolic blood pressure measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm
Time frame
10 Minutes3
Diastolic Blood Pressure
Upright systolic blood pressure measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt alone arm
Time frame
10 minutes4
Stroke volume
Upright stroke volume measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate salt alone arm
Time frame
10 minutesOther outcomes
1
Blood Volume
Blood volume measured at the end of the moderate dietary salt plus additional salt arm compared to the end of the moderate salt alone arm
Time frame
1 hour2
Upright Plasma Norepinephrine
Upright plasma norepinephrine measured during the tilt table test at the end of the moderate dietary salt plus additional salt arm compared to the tilt table test at the end of the moderate dietary salt arm
Time frame
10 minutesSponsors and contacts
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Source ClinicalTrials.gov