Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Background and Rationale: Postural Orthostatic Tachycardia Syndrome (POTS) is a form of autonomic cardiovascular disease, primarily in women, that is often disabling. The investigators and others have found that many patients with postural tachycardia have decreased plasma volume. Current POTS guidelines recommend ~10 g of salt and 2-3 L of fluid per day. In a proof of concept dietary salt study, the investigators recently showed 6 days of a high salt diet (300 mEq/d), compared to a low salt diet, increases plasma volume, reduced standing plasma norepinephrine, and reduced HR. The high salt diet reduced the median orthostatic tachycardia by 14 bpm. Currently there is only evidence showing the benefits of supplemental salt-intake over one week. It is unknown whether the increased blood volume from high dietary salt intake will persist over several weeks, or if an "escape mechanism" will reduce blood volumes back to baseline levels. This longer-term clinical trial of high dietary salt and water will address this "escape mechanism" and ongoing dietary compliance in POTS. Research Question & Objectives: Primary Hypothesis: The primary hypothesis is that after 6 weeks of a moderate dietary salt plus additional salt diet, the upright HR will be lower than after 6 weeks on a moderate dietary salt alone diet. Secondary hypotheses: The secondary hypotheses include: - Symptoms evaluated using the VOSS symptom score after 6 weeks of a moderate dietary salt plus additional salt diet will be reduced compared to after 6 weeks of a moderate dietary salt alone diet; - Upright stroke volume after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet; - Blood volume after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet; - Upright plasma catecholamines after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet; - Quality of life after 6 weeks of a moderate dietary salt plus additional salt diet will be increased compared to after 6 weeks of a moderate dietary salt alone diet. 3. Methods: Interventions: All participants will be instructed to each 5-6 g of salt per day in their diet. In the moderate dietary salt plus additional salt arm, participants will receive blinded capsules that contain 6g of salt per day (12x 500g slow- release capsules). They will take 2g of salt 3 times per day. Participants in the placebo arm will receive blinded capsules that contain 6g of microcrystalline cellulose. Protocol compliance will be assessed with 24h urine sodium. Randomization: This is a blinded cross-over study. The investigators will randomize patients to start with either salt capsules or placebo. After the 6-week study arm, participants will cross-over to the second study arm. Study Visit Schedule: The study will consist of three in-house study sessions: a baseline assessment, and an assessment at the end of each study arm: moderate dietary salt plus additional salt and placebo. The baseline visit will serve as a screening visit. Each study session will take place over 1 day in the Autonomic Lab at the University of Calgary. There will also be four 24hr urine sodium collections, and multiple online REDCap surveys. In-Lab Evaluation: The in-lab evaluation sessions while consist of autonomic function testing including a 10-minute tilt test, blood volume assessment, and supine and standing bloodwork. An IV will be started for the blood work. Urine Sodium: Participants will complete a 24-hr urine sodium test around the time of each in-lab evaluation, as well as before the 1 week study wash in. Study Surveys: At each assessment point (baseline and end of each arm), the investigators will send participants a secure REDCap survey link. At the end of the study, participants will also receive a patient experience survey. Participants will receive a total of 4 surveys. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05924646
Study type Interventional
Source University of Calgary
Contact Satish R Raj, MD MSCI
Phone 4032106152
Email autonomic.research@ucalgary.ca
Status Recruiting
Phase N/A
Start date May 7, 2024
Completion date December 31, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT05555771 - Paediatric Syncope in the Emergency Department N/A
Recruiting NCT05923840 - Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia N/A
Completed NCT05633407 - Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS Phase 2
Completed NCT03930914 - Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome N/A
Recruiting NCT00865917 - Cardiovascular Effects of Selective I(f)-Channel Blockade Phase 2
Recruiting NCT05741112 - The Long COVID-19 Wearable Device Study N/A
Recruiting NCT05454137 - A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS N/A
Enrolling by invitation NCT05877534 - Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study N/A
Completed NCT01367977 - Head Circumference Growth in Children With Ehlers-Danlos Syndrome Who Develop Dysautonomia Later in Life
Recruiting NCT04881318 - Compression Garments in the Community With POTS N/A
Recruiting NCT06292104 - Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
Completed NCT02171988 - Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS) Phase 4
Completed NCT01547117 - Dietary Salt in Postural Tachycardia Syndrome N/A
Completed NCT01617616 - Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects N/A
Completed NCT01563107 - Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome N/A
Active, not recruiting NCT02281097 - Transdermal Vagal Stimulation for POTS N/A
Completed NCT00728026 - Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea N/A
Recruiting NCT05481177 - Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort Phase 4
Not yet recruiting NCT05914649 - NC Testing in LC & POTS N/A
Completed NCT05404672 - Breathing Exercises With And Without Aerobic Training In Patients With Postural Orthostatic Tachycardia Syndrome N/A