Aldosterone & Sodium Regulation in Postural Tachycardia Syndrome - Screening
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01783288|
Recruitment Status : Active, not recruiting
First Posted : February 4, 2013
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postural Tachycardia Syndrome||Other: Autonomic Function Testing Other: Posture Study Procedure: Measurement of Total Blood Volume Other: Exercise Capacity Test||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aldosterone and Sodium Regulation in Postural Tachycardia Syndrome - Screening Protocol|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
All participants will be administered all procedures as described previously.
Autonomic Function Testing, Posture Study ,Measurement of Total Blood Volume ,Exercise Capacity Test
Other: Autonomic Function Testing
heart rate and blood pressure will be continuously monitored while participants undergo a variety of breathing techniques (deep breathing, rapid breathing, blowing against resistance) and during sustained handgrip and cold pressor (hand in ice water). All 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 autonomic nervous system is functioning.
Also during autonomic function testing, cardiac output will be measured to analyze the shift of fluids in the body (body impedance) and / or by analyzing the air that is breathed.
Other: Posture Study
Blood pressure, heart rate and blood samples (for catecholamines and hormones) will be measured & collected in the supine (lying) and upright position for each participant.
Other Name: Supine & standing blood pressure, heart rate & blood draws.
Procedure: Measurement of Total Blood Volume
Total blood volume is measured by using iodinated I-131 tagged human serum albumin.
Other: Exercise Capacity Test
Participants will ride on a stationary recumbent bicycle and the resistance will be gradually increased while expired air is measured.
Other Name: Masimal Oxygen Consumption Test
- blood volume deviation (%) from individual predicted volumes [ Time Frame: 2 days ]Compare blood volume deviations using the 131-I-Albumin method. Deviations will be reported as a percentage deviation from an individual's predicted value. These values will be compared between POTS patients and healthy control groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783288
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Emily Garland, PhD, MSCI||Vanderbilt University Medical Center|