Aldosterone & Sodium Regulation in Postural Tachycardia Syndrome - Screening
United States110 participantsStarted 2013-02
Plain-language summary
The purpose of the study is to determine whether patients meet criteria for Postural Tachycardia Syndrome (or not) and have reduced blood volume (or not). Both of these are important screening elements to Aim 3 of a National Institutes of Health Grant. The purposes of Aim 3 are to determine 1. whether a high dietary sodium level appropriately expands plasma volume in Postural Orthostatic Tachycardia, 2. whether plasma renin activity and aldosterone are modified appropriately by changes in dietary sodium in Postural Tachycardia Syndrome and 3. whether patients with Postural Tachycardia Syndrome have improvements in their orthostatic tachycardia and symptoms as a result of a high dietary sodium level.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18-50 years old
* Patients with suspected POTS and healthy volunteers
* Sedentary healthy subjects of similar age and gender than patients will also be recruited.
* Only female participants are eligible.
* Able and willing to provide informed consent
Exclusion Criteria:
* Smokers
* Overt cause for postural tachycardia, i.e., acute dehydration
* Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing
* Highly trained athletes
* Subjects with somatization or severe anxiety symptoms will be excluded
* Pregnant (positive pregnancy test) or breastfeeding
* Hypertension defined as supine resting BP\>145/95 mmHg off medications or needing antihypertensive medication
* 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
* Unable to give informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
blood volume deviation (%) from individual predicted volumes