Clinical Trial: Aldosterone & Sodium Regulation in Postural Tachycardia Syndrome - Screening

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome - Screening Protocol

Brief 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.

Detailed Summary:

The protocol consists of a screening visit and evaluation of their autonomic nervous system status. The following activities are part of this study. Subjects may stay for 2 nights and 3 study days.

Day 0 Participants will be admitted to the Clinical Research Center, their medical history, physical exam, routine lab work (hemoglobin/hematocrit & CMP) and a serum pregnancy test will be done during that first day. They will also be asked to fill out a health questionnaire. Later that day they will be evaluated to determine the extent of fatigue, depression and anxiety ratings, autonomic symptoms and quality of life, with the use of questionnaires.

Subjects may be asked to stop taking some medications for up to 7 days; it will be decided on an individual basis and after considering each medication and its effect to the autonomic nervous system. If subjects are asked to discontinue the medication, they will ask them to keep a diary of symptoms and to contact the PI or staff by phone if any new symptom appears. If necessary, medications will be restarted.

Testing day 1:

In the morning during the posture test, 5 teaspoons of blood will be drawn while subject is lying down, and after sitting and or standing for 30 minutes to measure substances produced by the body in response to inflammation and oxidative stress and to determine hormones that regulate the blood pressure. Blood pressure and heart rate will be measured in these different positions. A total of 10 tablespoons will be drawn.

In the afternoon, more tests will be performed designed to determine how well the autonomic nervous system is working in regulating blood pressure and heart rate. Autonomic function test will be p
Sponsor: Vanderbilt University

Current Primary Outcome: blood volume deviation (%) from individual predicted volumes [ Time Frame: 2 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Vanderbilt University Medical Center

Dates:
Date Received: January 25, 2013
Date Started: February 2013
Date Completion: February 2018
Last Updated: April 3, 2017
Last Verified: March 2017