Automated Abdominal Binder for Orthostatic Hypotension

Description

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.

Conditions

Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure, Multiple System Atrophy

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Study Overview

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Study Details

Study overview

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.

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

Automated Abdominal Binder for Orthostatic Hypotension

Condition
Orthostatic Hypotension
Intervention / Treatment

-

Contacts and Locations

Nashville

Autonomic Dysfunction Center/ Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Italo Biaggioni, MD, PRINCIPAL_INVESTIGATOR, Professor of Medicine and Pharmacology

Luis E Okamoto, MD, PRINCIPAL_INVESTIGATOR, Research Assistant Professor

Study Record Dates

2025-12-01