Automated Abdominal Binder for Orthostatic Hypotension

NCT03482297 | Completed Phase 1 DMC FDA Device

• 2 other identifiers: 1510081R01HL144568-01A1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

orthostatic hypotension; abdominal binder; pure autonomic failure; multiple system atrophy

Outcome Measures

Primary Outcomes (2)

• Orthostatic tolerance

  orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials

  After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day

• Orthostatic Hypotension Symptom Assessment (OHSA) Score

  The Orthostatic Hypotension Symptom Assessment (OHSA) Score is the part I of the Orthostatic Hypotension Questionnaire (OHQ). It consists of six questions, each rating the intensity of one characteristic symptom of orthostatic hypotension: 1. Dizziness, lightheadedness, feeling faint, or feeling like you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; and 6. Head/neck discomfort.The items are scored on an 11-point Likert scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst possible symptoms. Composite score is the average of the item scores obtained at the post-intervention stand period during the Morning Orthostatic Trials

  After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day

Secondary Outcomes (1)

• Upright time

  After 10 minutes of standing and 15 minutes waking (as tolerated)

Study Arms (2)

Automated Abdominal Binder

EXPERIMENTAL

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.

Device: automated abdominal binder; Drug: Placebo; Drug: Midodrine

Sham binder

SHAM COMPARATOR

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.

Device: Sham binder; Drug: Placebo; Drug: Midodrine

Interventions

Sham binder DEVICE

The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.

Sham binder

Placebo DRUG

Oral placebo will be given three times a day on the baseline day (placebo)

Automated Abdominal Binder; Sham binder

Midodrine DRUG

A midodrine pill 10mg will be given three times a day on the standard of care study day

Automated Abdominal Binder; Sham binder

automated abdominal binder DEVICE

The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.

Automated Abdominal Binder

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Vanderbilt University Medical Center: lead

Study Sites (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic; Pure Autonomic Failure; Multiple System Atrophy

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Italo Biaggioni, MD

  Professor of Medicine and Pharmacology

  PRINCIPAL INVESTIGATOR

• Luis E Okamoto, MD

  Research Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and investigators will be blinded as to the experimental interventions (active or sham abdominal binder, and placebo or midodrine pills)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Randomized, double-blind, sham-controlled, parallel-group, 3-study days inpatient study to compare the efficacy of the automated abdominal binder versus sham treatment in improving orthostatic tolerance in patients with primary autonomic failure disabled by neurogenic orthostatic hypotension.

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: March 29, 2018
• Study Start: March 1, 2018
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)