Automated Abdominal Binder for Orthostatic Hypotension

  • End date
    Dec 1, 2024
  • participants needed
  • sponsor
    Vanderbilt University Medical Center
Updated on 8 April 2023
systolic blood pressure
orthostatic hypotension
pure autonomic failure


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.


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.

Condition Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy
Treatment Placebo, Midodrine, automated abdominal binder, Sham binder
Clinical Study IdentifierNCT03482297
SponsorVanderbilt University Medical Center
Last Modified on8 April 2023


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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