Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01783288 |
| Other study ID # |
IRB 121817 |
| Secondary ID |
R01HL102387 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2013 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Vanderbilt University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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 performed to see how the involuntary nervous system is working. For these tests,
heart rate will be recorded using a continuous electrocardiographic trace, blood pressure
using a cuff around one arm and/or finger and heart's pumping capacity (cardiac output) will
be measured by analyzing the shift of fluids in the body (body impedance) and/or by analyzing
the air that is breathe.
Participants will be tilted up on a tilt table for 10 minutes while recording their heart
rate and blood pressure. The autonomic function tests include asking the participants to
breathe deeply for two minutes and breathing rapidly for 30 seconds, maintaining a handgrip
for 3 minutes, blowing against pressure for 15 seconds and placing one hand in ice water for
1 minute. All these tests are meant to stimulate the autonomic nervous system to produce
changes in blood pressure and heart rate of short duration that reflect how well the
involuntary nervous system is working.
Testing day 2:
In the morning, total blood volume will be measured by using iodinated I-131 tagged human
serum albumin, a material with a very small amount of radioactive substance. The test
involves drawing a blood sample before the I-131 is given, then giving the I-131 through a
catheter in one vein, waiting 12 minutes before the second blood sample is drawn to check its
concentration. Blood samples will also be drawn while subjects are lying down to measure for
hormones, which control blood pressure and heart rate. Blood will drawn at several points
during the study. The total amount of blood drawn during this study is approximately 3
teaspoons.
In the afternoon, exercise capacity test with estimation of maximal oxygen consumption (VO2
max) will be done. This test will be conducted on a stationary bicycle and the resistance
will be gradually increased while the expired air is measured during exhaustive physical
work. The test will last approximately 30 minutes. A mouthpiece with a one way re-breathing
valve attached to a breathing tube will be used to collect air samples during the exercise
test. Essentially, subjects will breathe room air through a mouthpiece, and then expire the
air into a tube that connects to a machine (metabolic cart). This machine analyzes carbon
dioxide and oxygen content, which allows us to calculate the amount of oxygen they are using
under resting and exercise conditions.
The workload will be gradually increased on the bike by increasing the resistance. As the
workload increases, oxygen consumption also increases. Throughout the test period exhaled air
will be collected. When subjects can no longer continue, the test will be stopped. Blood
pressure will be measured at the end of each resistance-stage. Heart rate data will be
recorded continuously.
Before and after completing the exercise test, subjects will be required to complete a
"warm-up" and "cool-down" session including stretching exercises.
