Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome

The purpose of this study is to see if people with Postural Tachycardia Syndrome (POTS) have different levels of certain chemicals in their blood than people who don't have POTS. This study will test whether the blood vessels of people with POTS will react differently to certain tests than people without POTS.

The hypothesis of the study is:

Patients with POTS will have vascular endothelial dysfunction compared with control subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postural Tachycardia Syndrome Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University, Nashville, Tennessee, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ALL:

Ages between 18-60 years old
Male and female subjects are eligible
Able and willing to give informed consent

Additional criteria for POTS:

Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic - Dysfunction Center (1. increase in heart rate >/= 30 beats/minute with position change from supine to standing for 10 minutes and/or 2. Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence.

Additional criteria for Control subjects:

Healthy, non-obese, non-smokers without orthostatic tachycardia
Selected to match profiles of POTS patients (gender, age)
Not using vasoactive medications

Exclusion criteria

Overt cause for postural tachycardia (such as acute dehydration)
Inability to give, or withdraw informed consent
Pregnancy
Other factors in the investigator's opinion would prevent the subject from completing the study

Treatment and study plan

Blood Pressure and Blood Flow

Device

A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The probes also measure blood pressure. After 10 minutes, the arm blood pressure cuff will be inflated. The cuff will stay inflated for 5 minutes, then the air will be let out. A cuff will be place above the left calf and the left knee. The subject will lie quietly for 9 minutes, then blood pressure and calf blood flow will be measured for one minute. the lower leg cuff will be inflated after 1 minute, then the cuff will be deflated. The blood pressure and forearm blood flow will be recorded. Next, the cuff on the upper leg will be inflated for 5 minutes then, it will be released and the measurements of blood pressure and calf blood flow will be repeated.

The study lasts about 2 hours.

Other names: Pulsitile Arterial Tonometry Protocol (PAT)

Primary outcomes

RH-PAT index

Time frame: The study will be complete in approximately 2 hours. There is no follow-up to this study.

The primary analysis of RH-PAT will involve a non-parametric, Mann Whitney U test of RH-PAT between POTS patients and Control subjects.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome (POTS)

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2017
First posted: Mar 3, 2011
Registry last updated: Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed