High Sodium Diet and External Abdominal Compression in POTS - Full Text View

Purpose

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	Intervention
Postural Orthostatic Tachycardia Syndrome	Device: External automated abdominal binder


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care
Official Title:	Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS

Resource links provided by NLM:

MedlinePlus related topics: Marijuana Mitral Valve Prolapse

Genetic and Rare Diseases Information Center resources: Postural Orthostatic Tachycardia Syndrome

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Change from baseline in orthostatic tachycardia [ Time Frame: 2 hours post baseline ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 2 hours post baseline ] [ Designated as safety issue: No ]
The secondary endpoint is the change from baseline in orthostatic symptoms (total score) 2 hours after baseline.


Estimated Enrollment:	20
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771484

Locations


United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Italo Biaggioni, MD 615-322-2931 adcresearch@vanderbilt.edu
Contact: Luis Okamoto, MD 615-322-2931 adcresearch@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	Italo Biaggioni, MD	Vanderbilt University

More Information

No publications provided


Responsible Party:	Italo Biaggioni, Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01771484 History of Changes
Other Study ID Numbers:	121178
Study First Received:	December 12, 2012
Last Updated:	November 20, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:


tachycardia pots orthostatic intolerance

Additional relevant MeSH terms:


Orthostatic Intolerance Postural Orthostatic Tachycardia Syndrome Autonomic Nervous System Diseases Nervous System Diseases	Neurologic Manifestations Primary Dysautonomias Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015