What side effects are associated with this type of intervention?

Common treatments for orthostatic hypotension that involve external pressure to increase venous return, such as abdominal binders, generally have minimal side effects. However, some patients may experience discomfort, skin irritation, or pressure sores from prolonged use. It is important to ensure proper fit and regular monitoring to mitigate these risks. Other treatments, like compression stockings, may also cause similar issues if not used correctly. Overall, these treatments are considered relatively safe when appropriately managed.

What prior FDA approvals exist?

The FDA has approved several treatments for orthostatic hypotension, though specific approvals for devices using external pressure to increase venous return, like the automated inflatable abdominal binder, are not detailed in the provided context. Generally, treatments for orthostatic hypotension include medications such as midodrine and fludrocortisone, which work by increasing blood pressure. Devices that apply external pressure, such as compression stockings, are also commonly used to manage symptoms by improving venous return.

What other types of research exist?

Promising novel alternatives to the Automated Inflatable Abdominal Binder for orthostatic hypotension include: 1) Pharmacological agents such as droxidopa, which increases norepinephrine levels to improve blood pressure; 2) Compression garments like graded compression stockings that enhance venous return; 3) Physical counter-maneuvers, including leg crossing and squatting, which can be taught to patients to manage symptoms; 4) Tilt training, a form of physical therapy that gradually acclimates patients to upright positions; and 5) Neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS), which are being explored for their potential to stabilize blood pressure.

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Device

Automated Abdominal Binder for Orthostatic Hypotension

Phase 1 & 2

Recruiting

Led By Italo Biaggioni, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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,

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.

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 10 minutes of standing and 15 minutes waking (as tolerated)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects could include discomfort from the binder's pressure, skin irritation where the device is worn, and typical reactions to Midodrine such as scalp tingling, itching, goosebumps, nausea or urinary urgency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 40 and 80 years old.

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I am between 40 and 80 years old.

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

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I experience significant dizziness or lightheadedness when standing, affecting my quality of life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am currently taking blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 10 minutes of standing (or as tolerated) during the morning orthostatic trial on the automated binder/sham study day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 10 minutes of standing (or as tolerated) during the morning orthostatic trial on the automated binder/sham study day

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 10 minutes of standing (or as tolerated) during the morning orthostatic trial on the automated binder/sham study day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Orthostatic Hypotension Symptom Assessment (OHSA) Score

Orthostatic tolerance

Secondary study objectives

Upright time

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Automated Abdominal BinderExperimental Treatment3 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 binderPlacebo Group3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midodrine

2008

Completed Phase 4

~1160

Placebo

1995

Completed Phase 3

~2670

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Orthostatic hypotension (OH) is a condition characterized by a significant drop in blood pressure upon standing, leading to dizziness or fainting. The primary goal of treatment is to improve venous return and stabilize blood pressure. One common mechanism involves the use of external pressure devices, such as the automated inflatable abdominal binder, which apply pressure to the abdomen to increase venous return to the heart. This helps maintain blood pressure when standing. Other treatments may include pharmacologic agents that increase blood volume or vascular resistance. These treatments are crucial for OH patients as they help prevent symptoms like dizziness and fainting, thereby improving their quality of life and reducing the risk of falls and related injuries.

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