Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01308099
Collaborator
(none)
26
2
71
13
0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Blood Pressure and Blood Flow

Study Design

Study Type:
Observational
Actual Enrollment :
26 participants
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Vascular Endothelial Function in Postural Tachycardia Syndrome (POTS)
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
POTS & Controls

Participants will have a physical prior to the study day and collect urine for 24 hours. On the study day the following procedures take place: After blood samples taken (about 2 tbsp), the subject will lie down. A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The arm blood pressure cuff will be inflated 60 points above the highest number on your normal blood pressure for five minutes. The blood pressure and forearm blood flow will be recorded. At the end of 5 minutes, the cuff will be released and the measurements of blood pressure and calf blood flow will be repeated. The brachial artery diameter and flow will be measured at baseline, during cuff inflation and for 3 minutes after deflation. The study lasts about 2 hours.

Device: Blood Pressure and Blood Flow
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)
  • Outcome Measures

    Primary Outcome Measures

    1. RH-PAT index [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    2 Vanderbilt University Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Alfredo Gamboa, Research Assistant Professor of Medicine, Vanderbilt University Medical Center
    ClinicalTrials.gov Identifier:
    NCT01308099
    Other Study ID Numbers:
    • 091332
    First Posted:
    Mar 3, 2011
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Alfredo Gamboa, Research Assistant Professor of Medicine, Vanderbilt University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2017