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High Sodium Diet and External Abdominal Compression in POTS

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
External automated abdominal binder
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postural Orthostatic Tachycardia Syndrome focused on measuring tachycardia, pots, orthostatic intolerance

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Postural Tachycardia Syndrome: Diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center
  • Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
  • Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
  • Participation in the parent study "Dietary Salt in Postural Tachycardia Syndrome" (IRB#111261)
  • Age between 18-60 years
  • Male and females
  • Able and willing to provide informed consent

Exclusion Criteria:

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Sodium Diet

High sodium diet

Arm Description

participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day.

Participants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention.

Outcomes

Primary Outcome Measures

Change from baseline in orthostatic tachycardia
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2012
Last Updated
January 16, 2017
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01771484
Brief Title
High Sodium Diet and External Abdominal Compression in POTS
Official Title
Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Not enough volunteer recruited before funding could be secured.
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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 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. At 1 and 2 hours post intervention, the subject will be asked to stand for up to 10 minutes while applying external automated abdominal binder compression (up to 40 mmHg). HR/BP will be measured at 1, 3, 5, and 10 minutes of standing. o If nursing staffing shortages make q1h standing difficult, then the subject should be asked to stand at least at 2 hours post intervention. Study termination for that day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome
Keywords
tachycardia, pots, orthostatic intolerance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Sodium Diet
Arm Type
Experimental
Arm Description
participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day.
Arm Title
High sodium diet
Arm Type
Experimental
Arm Description
Participants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention.
Intervention Type
Device
Intervention Name(s)
External automated abdominal binder
Intervention Description
Participants will wear the abdominal compression binder on day 4 or 5 of the study diet. Seated and standing vitals will be collected before and during application of binder.
Primary Outcome Measure Information:
Title
Change from baseline in orthostatic tachycardia
Description
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.
Time Frame
2 hours post baseline
Secondary Outcome Measure Information:
Title
Change from baseline in orthostatic symptoms
Description
The secondary endpoint is the change from baseline in orthostatic symptoms (total score) 2 hours after baseline.
Time Frame
2 hours post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postural Tachycardia Syndrome: Diagnosed with POTS by the Vanderbilt Autonomic Dysfunction Center Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes) Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence Participation in the parent study "Dietary Salt in Postural Tachycardia Syndrome" (IRB#111261) Age between 18-60 years Male and females Able and willing to provide informed consent Exclusion Criteria: Overt cause for postural tachycardia (such as acute dehydration) Inability to give, or withdrawal of, informed consent Pregnancy Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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High Sodium Diet and External Abdominal Compression in POTS

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