Assessing Aldosterone & Sodium Regulation in Postural Orthostatic Tachycardia Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Alfredo J Gamboa, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alfredo J Gamboa, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

Interventions

• Autonomic Function Testing (Other)
• Exercise Capacity Test (Other)
• Measurement of Total Blood Volume (Procedure)
• Posture Study (Other)

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.

Participant Groups

Group I: All participants Experimental Treatment 4 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

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

Robert L. Caldwell

Vanderbilt University

Chief Executive Officer since 2003

PhD in Pathology from Vanderbilt University

Rick Wright

Vanderbilt University

Chief Medical Officer since 2023

MD from Washington University School of Medicine in St. Louis

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University