Automated Abdominal Binder for Orthostatic Hypotension

Overseen By Luis E Okamoto, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Diabetes, Amyloidosis, Coronary artery disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 3 days

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an inflatable abdominal binder to assist individuals with orthostatic hypotension, a condition where blood pressure drops upon standing. The main goal is to determine if this binder is safe and effective for those whose bodies don't automatically adjust their blood pressure. Participants will use either the real binder or a sham version to compare effects. Suitable candidates are those experiencing moderate to severe dizziness or lightheadedness when standing, due to conditions like Multiple System Atrophy or Pure Autonomic Failure. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using anticoagulants (blood thinners).

What prior data suggests that this automated abdominal binder is safe for treating orthostatic hypotension?

Research has shown that the automated abdominal binder is generally easy to use and well-tolerated. This device inflates to apply pressure on the abdomen, aiding those with orthostatic hypotension—a condition that causes low blood pressure when standing—by improving their ability to stand without dizziness or fainting. Past studies have used similar devices safely, with few serious side effects reported.

The current phase of testing focuses on both safety and effectiveness, and earlier findings suggest that the binder rarely causes major problems. The device inflates to about 40 mmHg, which previous patients have handled well. So far, these studies have found no significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the automated abdominal binder for orthostatic hypotension because it offers a novel, non-drug approach to managing the condition. Unlike the standard treatment with medications like midodrine, this binder helps stabilize blood pressure by automatically inflating to about 40 mmHg every time the wearer stands up, reducing dizziness and fainting. This method provides an immediate mechanical support, which can be particularly beneficial for patients who prefer to avoid additional medication or those who do not respond well to current drug therapies.

What evidence suggests that the automated abdominal binder is effective for orthostatic hypotension?

Research has shown that the automated inflatable abdominal binder, a treatment in this trial, can help manage orthostatic hypotension, a condition where blood pressure drops upon standing. Studies have found that this binder works as effectively as midodrine, another treatment option in this trial and a common remedy for this condition. It improves orthostatic tolerance, making it easier for individuals to stand without feeling dizzy or faint. The binder inflates automatically to support blood flow when a person stands. This method has enhanced blood circulation and improved the ability to stand without issues. ^{3 6 7 8 9}

Who Is on the Research Team?

Italo Biaggioni, MD

Principal Investigator

Professor of Medicine and Pharmacology

Luis E Okamoto, MD

Principal Investigator

Research Assistant Professor

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with Multiple System Atrophy or Pure Autonomic Failure, who experience significant drops in blood pressure upon standing and have related symptoms impacting their quality of life. Pregnant individuals, those with certain systemic illnesses, recent surgery patients, and people on anticoagulants cannot participate.

Inclusion Criteria

My blood pressure drops significantly when I stand, due to nerve issues.

I often feel dizzy or faint when standing up, and it affects my daily life.

I am between 40 and 80 years old.

Exclusion Criteria

I have not had major surgery, severe hernias, intense acid reflux, recent bone fractures, or devices that could interfere with abdominal pressure in the last 6 months.

I am bedridden or cannot stand due to severe mobility issues.

I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Measurements

Participants undergo baseline measurements with placebo pill administration

1 day

1 visit (in-person)

Treatment

Participants receive treatment with 10 mg midodrine t.i.d and automated or sham abdominal binder

3 days

3 visits (in-person, two days apart)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Automated Abdominal Binder
• Midodrine
• Placebo
• Sham Binder

Trial Overview The study tests an automated abdominal binder against a sham binder to see if it helps manage low blood pressure when standing due to autonomic failure. Participants may also receive Midodrine (a drug for low blood pressure) or placebo as part of the trial.

How Is the Trial Designed?

Group I: Automated Abdominal Binder Experimental Treatment 3 Interventions

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.

Group II: Sham binder Placebo Group 3 Interventions

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.

Automated Abdominal Binder is already approved in United States for the following indications:

Approved in United States as Automated Abdominal Binder for:

• Orthostatic Hypotension

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The automated inflatable abdominal binder provides effective venous compression and improves orthostatic tolerance in patients with autonomic failure, showing similar efficacy to the standard treatment, midodrine, in a study of 19 patients.

Combining the binder with midodrine significantly enhances orthostatic tolerance and reduces symptoms more than either treatment alone, indicating a potential for improved management of orthostatic hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Servo-Controlled Splanchnic Venous Compression in the Treatment of Orthostatic Hypotension: A Randomized Comparison With Midodrine. Okamoto, LE., Diedrich, A., Baudenbacher, FJ., et al.[2018]

The abdominal compression binder significantly increases venous volume in the lower extremities, leading to reduced stroke volume and cardiac output in 25 healthy subjects, indicating a notable impact on central and peripheral haemodynamics.

While the binder does not affect pulmonary volumes, its use in the supine position for extended periods should be approached with caution due to the potential risk of deep venous thrombosis from blood pooling in the legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemodynamic and respiratory effects of an abdominal compression binder. Toft, MH., Bülow, J., Simonsen, L.[2008]

The use of an abdominal binder significantly improved respiratory function in individuals with tetraplegic spinal cord injuries, enhancing vital capacity and forced vital capacity after a 6-week trial.

However, the abdominal binder did not show any significant benefits for speech production, as no improvements were observed in various speech parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an abdominal binder on speech outcomes in people with tetraplegic spinal cord injury: perceptual and acoustic measures. Cornwell, PL., Ward, EC., Lim, Y., et al.[2021]

The 'Ball and Binder' device, an innovative and low-cost pneumatic abdominal compression tool, significantly reduced distal aortic blood flow by over 50% in a study of nine healthy volunteers.

This device offers a promising new option for rapidly treating postpartum hemorrhage, especially in cases where standard treatments are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of Pelvic Blood Flow Using a Novel Pneumatic Abdominal Binder. [2021]

In a study involving 15 patients with Parkinson's disease, the use of an elastic abdominal binder significantly reduced the drop in blood pressure when standing, with an average increase of 10 mm Hg compared to a placebo.

Symptoms of orthostatic hypotension improved significantly during a 4-week follow-up period, indicating that elastic abdominal binders could be an effective complementary treatment for managing this condition in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. Fanciulli, A., Goebel, G., Metzler, B., et al.[2022]

This study quantitatively analyzed the effectiveness of inflatable abdominal binders for managing orthostatic hypotension, showing that they can provide consistent pressure across different areas of the abdomen without significant differences in pressure exerted on the body.

The research developed a model that correlates the pressure in the inflatable bladder to the actual pressure experienced by the patient, ensuring safety and effectiveness in treatment, which is crucial for nonpharmacological management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Abdominal Constrictor's Forces for Informing Computational Models of Orthostatic Hypotension. Syed, F., Jose, R., Devine, T., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27271310/

A Randomized Comparison With Midodrine - PubMed - NIH Servo-controlled abdominal venous compression with an automated inflatable binder is as effective as midodrine, the standard of care, in the management of ...

2. ahajournals.org ahajournals.org/doi/10.1161/hypertensionaha.116.07199

Efficacy of Servo-Controlled Splanchnic Venous ... In this proof-of-concept study, the automated inflatable abdominal binder acutely improved orthostatic tolerance. Longer-term studies are ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03482297

Automated Abdominal Binder for Orthostatic Hypotension | ... The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients.

4. mdpi.com mdpi.com/2039-7283/14/5/138

A Safety-Centric Study on the Use of Inflatable Abdominal ... The results showed that the use of an elastic abdominal binder was associated with improved orthostatic tolerance in PD patients with OH. A ...

5. ahajournals.org ahajournals.org/doi/10.1161/hyp.62.suppl_1.A531

Abstract 531: Splanchnic Venous Compression With an ... In conclusion, the automated inflatable abdominal binder is as effective as midodrine, the standard of care, in the management of OH, without increasing seated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11417920/

A Safety-Centric Study on the Use of Inflatable Abdominal ... The results showed that the use of an elastic abdominal binder was associated with improved orthostatic tolerance in PD patients with OH. A ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4945429/

EFFICACY OF SERVO-CONTROLLED SPLANCHNIC ... We developed an automated inflatable abdominal binder that provides sustained servo-controlled venous compression (40 mmHg) and can be activated only on ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03482297/automated-abdominal-binder-for-orthostatic-hypotension

Automated Abdominal Binder for Orthostatic Hypotension The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these ...

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.016196

Splanchnic Venous Compression Enhances the Effects of ... To assess whether abdominal compression attenuates orthostatic tachycardia and improves symptoms, 18 postural tachycardia syndrome patients (32± ...