- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771484
High Sodium Diet and External Abdominal Compression in POTS
Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Sodium Diet
participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours post baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 121178
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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