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Assessing Aldosterone & Sodium Regulation in Postural Orthostatic Tachycardia Syndrome

N/A

Waitlist Available

Led By Alfredo J Gamboa, MD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-50 years old

Only female participants are eligible

Must not have

Subjects with somatization or severe anxiety symptoms will be excluded

Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is important to determine if patients have Postural Tachycardia Syndrome and reduced blood volume, and if a high dietary sodium level can help improve symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct side effects from the interventions as they involve non-invasive tests like measuring blood volume and heart rate responses to posture changes. However, discomfort from participating in these activities might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I am a female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe anxiety or somatization symptoms.

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I have a serious heart, lung, liver, or blood disease.

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I have a rapid heartbeat when standing up due to dehydration.

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I have high blood pressure or take medication for it.

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I am unable to understand and agree to the study's details on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

blood volume deviation (%) from individual predicted volumes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment4 Interventions

All participants will be administered all procedures as described previously. Interventions: Autonomic Function Testing, Posture Study ,Measurement of Total Blood Volume ,Exercise Capacity Test

0 / 7Eligibility criteria met