Orthostatic HypotensionPhase 1/2NCT03482297
Automated Abdominal Binder for Orthostatic Hypotension
A Phase 1/2 study testing automated abdominal binder and Midodrine in people with Orthostatic Hypotension and Autonomic Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure
- What is being tested?
- automated abdominal binder and Midodrine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 19 Nov 2025
- Phase
- Phase 1/2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, age 40-80 years.
- Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria.
- Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes, and
- Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient.
- Able and willing to provide informed consent.
Who cannot join
- Pregnancy.
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux; recent fractures or fissures of ribs, thoracic or lumbar spine; medical devices implanted on the abdominal wall or abdomen that would interfere with the binder; known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase in intraabdominal pressure.
- Pre-existing sustained supine hypertension ≥180/110.
- Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
- Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke or transient ischemic attacks).
- Concomitant use of anticoagulants
Trial locations and contacts
1 site in 1 country.
United States1 site
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Randomized, Double-blind, Sham-controlled to Evaluate the Effects of an Automated Abdominal Binder in Improving Orthostatic Tolerance in Autonomic Failure Patients With Disabling Orthostatic Hypotension
The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients.
Read the detailed description
This is a randomized, double-blind, sham-controlled, parallel group study to compare the efficacy of the automated abdominal binder (inflated to 40 mm Hg) versus sham treatment (abdominal binder inflated to 5 mm Hg) in improving orthostatic tolerance in patients with primary autonomic failure disabled by orthostatic hypotension.
Potential participants will be admitted to the Vanderbilt Clinical Research Center for evaluation of inclusion and exclusion criteria. Eligible patients will be randomized to the active or sham binder group. Patients will then be asked to participate on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with active or sham binder combined with placebo pill t.i.d. The order of the study days will be randomized. On each study day, blood pressure and heart rate will be measured while sitting, lying down, standing and walking during the Morning Orthostatic Trial, and posture and walking tests.
- Conditions
- Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
- Being tested
- automated abdominal binder, Sham binder, Placebo, Midodrine
- Keywords
- orthostatic hypotension, abdominal binder, pure autonomic failure, multiple system atrophy
- Medical subject headings
- Hypotension, Orthostatic, Pure Autonomic Failure, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated abdominal binderDevice
The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.
Sham binderDevice
The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.
PlaceboDrug
Oral placebo will be given three times a day on the baseline day (placebo)
MidodrineDrug
A midodrine pill 10mg will be given three times a day on the standard of care study day
| Study group | Role | What they receive |
|---|---|---|
| Automated Abdominal Binder | Experimental | Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the automated abdominal binder combined with placebo pill t.i.d The automated abdominal binder will be placed during the morning orthostatic trial on the active/sham binder study day. The binder will inflate automatically (~40 mmHg) every time the participant stands up throughout the study day. Receives: Device: automated abdominal binder; Drug: Placebo; Drug: Midodrine |
| Sham binder | Sham comparator | Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (~5 mmHg) every time the participant stands up throughout the study day. Receives: Device: Sham binder; Drug: Placebo; Drug: Midodrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic tolerance
orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials
Measured: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Orthostatic Hypotension Symptom Assessment (OHSA) Score
The Orthostatic Hypotension Symptom Assessment (OHSA) Score is the part I of the Orthostatic Hypotension Questionnaire (OHQ). It consists of six questions, each rating the intensity of one characteristic symptom of orthostatic hypotension: 1. Dizziness, lightheadedness, feeling faint, or feeling like you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; and 6. Head/neck discomfort.The items are scored on an 11-point Likert scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst possible symptoms. Composite score is the average of the item scores obtained at the post-intervention stand period during the Morning Orthostatic Trials
Measured: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Secondary outcomes (1)
Upright time
Sum of standing and walking times
Measured: After 10 minutes of standing and 15 minutes waking (as tolerated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Mar 2018
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, sham-controlled, parallel-group, 3-study days inpatient study to compare the efficacy of the automated abdominal binder versus sham treatment in improving orthostatic tolerance in patients with primary autonomic failure disabled by neurogenic orthostatic hypotension.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Luis E Okamoto, Vanderbilt University Medical Center
- Investigators
- Italo Biaggioni, MD, Principal investigator, Professor of Medicine and PharmacologyLuis E Okamoto, MD, Principal investigator, Research Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482297
- Sponsor's protocol ID
- 151008
- Other IDs
- 1R01HL144568-01A1
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Sham-controlled to Evaluate the Effects of an Automated Abdominal Binder in Improving Orthostatic Tolerance in Autonomic Failure Patients With Disabling Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT03482297
- Acronym / sponsor ID
- 151008
- Conditions
- Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
- Keywords
- orthostatic hypotension, abdominal binder, pure autonomic failure, multiple system atrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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 automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients.
Detailed description
This is a randomized, double-blind, sham-controlled, parallel group study to compare the efficacy of the automated abdominal binder (inflated to 40 mm Hg) versus sham treatment (abdominal binder inflated to 5 mm Hg) in improving orthostatic tolerance in patients with primary autonomic failure disabled by orthostatic hypotension.
Potential participants will be admitted to the Vanderbilt Clinical Research Center for evaluation of inclusion and exclusion criteria. Eligible patients will be randomized to the active or sham binder group. Patients will then be asked to participate on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with active or sham binder combined with placebo pill t.i.d. The order of the study days will be randomized. On each study day, blood pressure and heart rate will be measured while sitting, lying down, standing and walking during the Morning Orthostatic Trial, and posture and walking tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, sham-controlled, parallel-group, 3-study days inpatient study to compare the efficacy of the automated abdominal binder versus sham treatment in improving orthostatic tolerance in patients with primary autonomic failure disabled by neurogenic orthostatic hypotension.
| Arm | Type | Receives |
|---|---|---|
| Automated Abdominal Binder | Experimental | Device: automated abdominal binder, Drug: Placebo, Drug: MidodrineParticipants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the automated abdominal binder combined with placebo pill t.i.d The automated abdominal binder will be placed during the morning orthostatic trial on the active/sham binder study day. The binder will inflate automatically (~40 mmHg) every time the participant stands up throughout the study day. |
| Sham binder | Sham comparator | Device: Sham binder, Drug: Placebo, Drug: MidodrineParticipants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (~5 mmHg) every time the participant stands up throughout the study day. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects, age 40-80 years.
- Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria.
- Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes, and
- Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient.
- Able and willing to provide informed consent.
Key exclusion criteria (7 listed)
- Pregnancy.
- Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
- History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux; recent fractures or fissures of ribs, thoracic or lumbar spine; medical devices implanted on the abdominal wall or abdomen that would interfere with the binder; known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase in intraabdominal pressure.
- Pre-existing sustained supine hypertension ≥180/110.
- Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
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 |
|---|---|---|
| automated abdominal binderThe binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day. | Device | Automated Abdominal Binder |
| Sham binderThe binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day. | Device | Sham binder |
| PlaceboOral placebo will be given three times a day on the baseline day (placebo) | Drug | Automated Abdominal Binder, Sham binder |
| MidodrineA midodrine pill 10mg will be given three times a day on the standard of care study day | Drug | Automated Abdominal Binder, Sham binder |
Primary outcome
Orthostatic tolerance
Time frame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials
Orthostatic Hypotension Symptom Assessment (OHSA) Score
Time frame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
The Orthostatic Hypotension Symptom Assessment (OHSA) Score is the part I of the Orthostatic Hypotension Questionnaire (OHQ). It consists of six questions, each rating the intensity of one characteristic symptom of orthostatic hypotension: 1. Dizziness, lightheadedness, feeling faint, or feeling like you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; and 6. Head/neck discomfort.The items are scored on an 11-point Likert scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst possible symptoms. Composite score is the average of the item scores obtained at the post-intervention stand period during the Morning Orthostatic Trials
1 secondary outcome
Upright time
Time frame: After 10 minutes of standing and 15 minutes waking (as tolerated)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
Related trials for Orthostatic Hypotension
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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
Professor of Medicine and Pharmacology
Luis E Okamoto, MD principal investigator
Research Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing automated abdominal binder and Midodrine in people with Orthostatic Hypotension and Autonomic Failure, run by Vanderbilt University Medical Center 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 5 May 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Orthostatic tolerance (time frame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day). The study lists 2 primary outcomes in all. 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 5 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.