Clinical Trial: High Sodium Diet and External Abdominal Compression in POTS

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS

Brief Summary: The investigators will test to determine if an external Automated Abdominal Binder (non-commercial product) during high sodium diet improves orthostatic tolerance, compared to wearing the binder during a low sodium diet session.

Detailed Summary:

The study will involve a crossover design in which each subject will be assessed (as below) while on a very low-sodium (10 milliequivalent/day) diet compared with a very high-sodium diet (300 milliequivalent/day). These acute dietary interventions will be part of the parent study ("Dietary Salt in Postural Tachycardia Syndrome" IRB#111261) for 4-5 days at the time of the study. Dietary success will be assessed using a 24h urine for sodium and creatinine as a part of the parent study.

Study Day:

  • Studies will be performed at the end of the low and high-sodium diet phases.
  • Blood pressure recording will not begin until at least 2 hours after the last meal (to avoid any confounding hypotension from the last meal).
  • Subject will be asked to void prior to data collection.
  • The subject will be seated in a chair, with their feet comfortably on the floor.
  • The Dinamap electrocardiographic and blood pressure (brachial cuff) recorder will be attached to the patient and set up for measurements every 10 minutes throughout the study with digital download into the Autonomic Dysfunction Center BP database.
  • After a 20-minute seated baseline, the subject will stand for up to10 minutes. Heart rate and blood pressure (HR/BP) will be measured at 1, 3, 5, and 10 minutes of standing. At the end of the baseline stand period, subjects will be asked to rate their symptoms using the provided orthostatic intolerance Symptoms questionnaire.
  • The subject will then be seated and the abdominal binder will be applied without compression.
  • The Dinamap electrocardiographic and bloo
    Sponsor: Vanderbilt University

    Current Primary Outcome: Change from baseline in orthostatic tachycardia [ Time Frame: 2 hours post baseline ]

    The primary end point is the change from baseline in orthostatic heart rate (change in HR on standing from a seated position) 2 hrs after baseline.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Change from baseline in orthostatic symptoms [ Time Frame: 2 hours post baseline ]

    The secondary endpoint is the change from baseline in orthostatic symptoms (total score) 2 hours after baseline.


    Original Secondary Outcome: Same as current

    Information By: Vanderbilt University Medical Center

    Dates:
    Date Received: December 12, 2012
    Date Started: December 2012
    Date Completion:
    Last Updated: January 16, 2017
    Last Verified: January 2017