Assessing Aldosterone & Sodium Regulation in Postural Orthostatic Tachycardia Syndrome

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Vanderbilt University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a high-sodium diet affects blood volume and symptoms in individuals with Postural Orthostatic Tachycardia Syndrome (POTS), a condition characterized by a rapid heartbeat and dizziness upon standing. Researchers aim to determine if increasing salt intake can improve these symptoms by expanding blood volume and altering certain hormones. Participants will undergo various tests, including assessments of blood volume and heart function through autonomic function testing and exercise capacity tests. Women who suspect they have POTS or are healthy but sedentary may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding POTS and potentially improve symptom management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on antihypertensive medication, you may not be eligible to participate.

What prior data suggests that these procedures are safe?

Research has shown that tests like Autonomic Function Testing and Exercise Capacity Tests are generally safe. These tests help doctors understand how the body functions in various situations. Commonly used in medical settings, they are usually well-tolerated by patients.

The study also involves measuring total blood volume and assessing posture. These standard procedures provide important health information and should not cause significant discomfort or risks.

As this study does not test new drugs or treatments, it focuses on understanding how different factors affect Postural Orthostatic Tachycardia Syndrome. The procedures aim to gather information rather than introduce new treatments, suggesting a lower risk for side effects.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to unravel how aldosterone and sodium regulation might play a role in managing Postural Orthostatic Tachycardia Syndrome (POTS). Unlike current treatments that often focus on symptom management with medications like beta-blockers or fludrocortisone, this study explores a comprehensive approach including autonomic function testing and measuring total blood volume. By understanding these underlying mechanisms, it could lead to more targeted and effective treatment strategies for POTS, potentially offering better symptom control and enhancing patients' quality of life.

What evidence suggests that this trial's procedures could be effective for Postural Orthostatic Tachycardia Syndrome?

Research has shown that increasing salt intake might benefit people with Postural Orthostatic Tachycardia Syndrome (POTS). Some studies suggest that a high salt intake can increase blood volume, potentially reducing the rapid heartbeat and dizziness often experienced when standing. Salt may also help regulate hormones like aldosterone, which affect blood pressure and fluid levels. Although researchers continue to study this treatment, these findings suggest that dietary changes could help manage POTS symptoms.

Who Is on the Research Team?

AJ

Alfredo J Gamboa, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 18-50 who may have Postural Tachycardia Syndrome (POTS) or are healthy but sedentary. Participants should not smoke, be pregnant, highly athletic, or have significant health issues like heart disease. They must be able to consent and follow the study schedule.

Inclusion Criteria

People with suspected POTS (Postural Orthostatic Tachycardia Syndrome) and those who are healthy.
I am a female.
Able and willing to provide informed consent
See 1 more

Exclusion Criteria

Pregnant (positive pregnancy test) or breastfeeding
I do not have severe anxiety or somatization symptoms.
Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Evaluation

Evaluation of autonomic nervous system status and initial assessments

3 days
3 visits (in-person)

Testing

Autonomic function testing, posture study, measurement of total blood volume, and exercise capacity test

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Autonomic Function Testing
  • Exercise Capacity Test
  • Measurement of Total Blood Volume
  • Posture Study
Trial Overview The study aims to see if high sodium diets can increase blood volume and improve symptoms in POTS patients by testing their exercise capacity, autonomic functions, posture response, and total blood volume before and after dietary changes.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: All participantsExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials
714
Recruited
6,143,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

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