Nashville, Tennessee 37232

  • Postural Orthostatic Tachycardia Syndrome

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.


Study 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 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.


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.


Study is Available At:


Original ID:

121178


NCT ID:

NCT01771484


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Not enough volunteer recruited before fundin


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

Official Name:Italo Biaggioni, MD
Principal Investigator
Vanderbilt University

Study Dates

Start Date:December 2012
Completion Date:January 2017
Completion Type:Actual
Primary Completion Date:January 2017
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 16, 2017
First Received Date:December 12, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in orthostatic symptoms
Time Frame:2 hours post baseline
Safety Issues:False
Description:The secondary endpoint is the change from baseline in orthostatic symptoms (total score) 2 hours after baseline.
Outcome Type:Primary Outcome
Measure:Change from baseline in orthostatic tachycardia
Time Frame:2 hours post baseline
Safety Issues:True
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.

Study Interventions

Intervention Type:Device
Name:External automated abdominal binder
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.
Arm Name:Low Sodium Diet

Study Arms

Study Arm Type:Experimental
Arm Name:High sodium diet
Description:Participants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention.
Study Arm Type:Experimental
Arm Name:Low Sodium Diet
Description:participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 26, 2021

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