Automated Abdominal Binder for Orthostatic Hypotension

Recruiting in Palo Alto (17 mi)

Overseen by Luis E Okamoto, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Diabetes, Amyloidosis, Coronary artery disease, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a special belt that inflates to help people with low blood pressure when they stand up. It targets patients who have a condition that makes it hard for them to keep their blood pressure stable. The belt works by squeezing the abdomen to help keep blood flowing properly when standing.

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 data supports the effectiveness of the Automated Abdominal Binder treatment for orthostatic hypotension?

Research shows that an automated inflatable abdominal binder can improve orthostatic tolerance (ability to stand without symptoms) similarly to midodrine, a common medication for orthostatic hypotension. The binder reduces orthostatic symptoms by providing sustained pressure, which helps manage blood flow when standing. ^{1 2 3 4 5}

Is the Automated Abdominal Binder safe for use in humans?

The Automated Abdominal Binder has been shown to affect blood flow and pressure in the body, which can be beneficial for certain conditions like orthostatic hypotension. However, it should be used with caution, especially when lying down for long periods, as it may increase the risk of blood clots in the legs. ^{1 2 3 4 5}

How does the Automated Abdominal Binder treatment differ from other treatments for orthostatic hypotension?

The Automated Abdominal Binder is unique because it provides targeted, adjustable pressure to the abdomen to prevent blood from pooling in the splanchnic veins (veins in the abdomen) when standing, unlike traditional medications that do not specifically address this issue. It is activated only when standing, offering a non-drug alternative that directly addresses the cause of orthostatic hypotension. ^{1 2 3 5 6}

Research Team

Italo Biaggioni, MD

Principal Investigator

Professor of Medicine and Pharmacology

Luis E Okamoto, MD

Principal Investigator

Research Assistant Professor

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Automated Abdominal Binder (Device)
• Midodrine (Alpha-1 Agonist)
• Placebo (Drug)
• Sham Binder (Device)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

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]

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 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]

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]

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]

References

1. Nepal pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Impact of an abdominal binder on speech outcomes in people with tetraplegic spinal cord injury: perceptual and acoustic measures. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Servo-Controlled Splanchnic Venous Compression in the Treatment of Orthostatic Hypotension: A Randomized Comparison With Midodrine. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Haemodynamic and respiratory effects of an abdominal compression binder. [2008]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of Abdominal Constrictor's Forces for Informing Computational Models of Orthostatic Hypotension. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. [2022]