High Sodium Diet and External Abdominal Compression in POTS

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Postural Orthostatic Tachycardia Syndrome	Device: External automated abdominal binder	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	13 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Participant)
Primary Purpose:	Supportive Care
Official Title:	Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS
Study Start Date :	December 2012
Actual Primary Completion Date :	January 2017
Actual Study Completion Date :	January 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Low Sodium Diet; participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day.	Device: External automated abdominal binder; 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.
Experimental: High sodium diet; Participants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention.	Device: External automated abdominal binder; 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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:	Italo Biaggioni, MD	Vanderbilt University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Italo Biaggioni, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01771484 History of Changes
Other Study ID Numbers:	121178
First Posted:	January 18, 2013
Last Update Posted:	January 18, 2017
Last Verified:	January 2017

Keywords provided by Italo Biaggioni, Vanderbilt University:

tachycardia; pots; orthostatic intolerance

Additional relevant MeSH terms:

Tachycardia; Orthostatic Intolerance; Postural Orthostatic Tachycardia Syndrome; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases	Pathologic Processes; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms