RecruitingNot ApplicableNCT05924646

CAlgary SAlt for POTS

CAlgary SAlt for Postural Orthostatic Tachycardia Syndrome Study


Sponsor

University of Calgary

Enrollment

50 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

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Interventions

DIETARY_SUPPLEMENTSodium Chloride Capsules

Table salt in slow release capsules.

OTHERMicrocystalline Cellulose Capsules

Microcrystalline Cellulose Capsules (Placebo)


Locations(1)

University of Calgary

Calgary, Alberta, Canada

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NCT05924646


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