| NCT ID | NCT05924646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Calgary |
| Condition | Postural Orthostatic Tachycardia Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-05-07 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Satish R Raj
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT05924646 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Postural Orthostatic Tachycardia Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05924646 currently recruiting?
Yes, NCT05924646 is actively recruiting participants. Contact the research team at autonomic.research@ucalgary.ca for enrollment information.
Where is the NCT05924646 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05924646 clinical trial?
NCT05924646 is sponsored by University of Calgary. The principal investigator is Satish R Raj at University of Calgary. The trial plans to enroll 50 participants.