CAlgary SAlt for POTS

NCT05924646 | Recruiting

• 1 other identifier: REB23-0779
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

Sodium; Salt; Treatment

Outcome Measures

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

  10 Minutes

Secondary Outcomes (4)

• Vanderbilt Orthostatic Symptom Score (VOSS)

  10 Minutes

• Systolic Blood Pressure

  10 Minutes

• Diastolic Blood Pressure

  10 minutes

• Stroke volume

  10 minutes

Other Outcomes (2)

• Blood Volume

  1 hour

• Upright Plasma Norepinephrine

  10 minutes

Study Arms (2)

Moderate Dietary Salt Plus Additional Salt

EXPERIMENTAL

6 grams of salt in slow release capsules combined with 6 grams of salt in the diet.

Dietary Supplement: Sodium Chloride Capsules

Moderate Dietary Salt Alone

PLACEBO COMPARATOR

6 grams of microcrystalline cellulose in slow release capsules combined with 6 grams of salt in the diet.

Other: Microcystalline Cellulose Capsules

Interventions

Sodium Chloride Capsules DIETARY_SUPPLEMENT

Table salt in slow release capsules.

Moderate Dietary Salt Plus Additional Salt

Microcystalline Cellulose Capsules OTHER

Microcrystalline Cellulose Capsules (Placebo)

Moderate Dietary Salt Alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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.
• Ability to attend the Calgary Autonomic Research Clinic in Calgary.
• Resident of Canada

You may not qualify 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 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Satish R Raj

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish R Raj, MD MSCI

CONTACT

4032106152; autonomic.research@ucalgary.ca

Tanya Siddiqui, MBBS

CONTACT

autonomic.research@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study participants and investigators will be blinded throughout the duration of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cross-over trial with two arms: high salt and normal salt (placebo).

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 29, 2023
• Study Start: May 7, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CA (1)