Postural Orthostatic Tachycardia SyndromePhase 1NCT01771484
High Sodium Diet and External Abdominal Compression in POTS
A Phase 1 study testing External automated abdominal binder in people with Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- External automated abdominal binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS
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.
Read the 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.
- 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.
- Being tested
- External automated abdominal binder
- Keywords
- tachycardia, pots, orthostatic intolerance
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Tachycardia, Orthostatic Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External automated abdominal binderDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Sodium Diet | Experimental | participants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day. Receives: Device: External automated abdominal binder |
| High sodium diet | Experimental | Participants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention. Receives: Device: External automated abdominal binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours post baseline
Secondary outcomes (1)
Change from baseline in orthostatic symptoms
The secondary endpoint is the change from baseline in orthostatic symptoms (total score) 2 hours after baseline.
Measured: 2 hours post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Not enough volunteer recruited before funding could be secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Italo Biaggioni, Vanderbilt University
- Investigators
- Italo Biaggioni, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771484
- Sponsor's protocol ID
- 121178
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2012
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of High-Sodium Diet and External Abdominal Compression in the Treatment of Orthostatic Intolerance in POTS
- ClinicalTrials.gov ID
- NCT01771484
- Acronym / sponsor ID
- 121178
- Keywords
- tachycardia, pots, orthostatic intolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough volunteer recruited before funding could be secured.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Sodium Diet | Experimental | Device: External automated abdominal binderparticipants will consume a diet (10 milliequivalent Na+/day)for 4-5 days prior to study day. |
| High sodium diet | Experimental | Device: External automated abdominal binderParticipants will consume a diet high in sodium (300 milliequivalent Na+/day) for 4-5 days prior to study intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External automated abdominal binderParticipants 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. | Device | High sodium diet, Low Sodium Diet |
Primary outcome
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.
1 secondary outcome
Change from baseline in orthostatic symptoms
Time frame: 2 hours post baseline
Results and safety
The study was stopped early (reason given: Not enough volunteer recruited before funding could be secured.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Italo Biaggioni, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing External automated abdominal binder in people with Postural Orthostatic Tachycardia Syndrome, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough volunteer recruited before funding could be secured.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in orthostatic tachycardia (time frame: 2 hours post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017; AzTrials last refreshed its copy on 31 Oct 2026.