High salt diet for treating Postural Orthostatic Tachycardia Syndrome
CAlgary SAlt for Postural Orthostatic Tachycardia Syndrome Study
NA · University of Calgary · NCT05924646
This study tests if a high salt diet can help people with Postural Orthostatic Tachycardia Syndrome feel better by improving their symptoms and blood volume.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05924646 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a high salt diet on patients with Postural Orthostatic Tachycardia Syndrome (POTS), a condition characterized by excessive heart rate increase upon standing. Participants will be randomly assigned to either a high salt diet or a normal salt diet over a three-month period, with evaluations including autonomic function testing and blood volume measurements. The study aims to determine if increased dietary salt can sustain elevated plasma volume and improve symptoms over a longer duration than previously studied. The trial will also assess the potential for an 'escape mechanism' that may negate the benefits of increased salt intake.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with a physician diagnosis of POTS who can attend the Calgary Autonomic Research Clinic.
Not a fit: Patients with other underlying causes of tachycardia or those with severe anxiety symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary approach to effectively manage symptoms of POTS and improve patients' quality of life.
How similar studies have performed: Previous short-term studies have shown benefits of increased salt intake in POTS, but this trial aims to explore the long-term effects, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Satish R Raj — University of Calgary
- Study coordinator: Satish R Raj, MD MSCI
- Email: autonomic.research@ucalgary.ca
- Phone: 4032106152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postural Orthostatic Tachycardia Syndrome, Sodium, Salt, Treatment