Automated abdominal binder for treating low blood pressure upon standing

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

This study is testing a new automatic abdominal binder to see if it can help people with low blood pressure when standing up feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT03482297 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of an automated inflatable abdominal binder designed to treat orthostatic hypotension in patients with autonomic failure. The study employs a randomized, double-blind, sham-controlled methodology, comparing the active binder inflated to 40 mm Hg against a sham binder inflated to 5 mm Hg. Participants will undergo a series of evaluations at the Vanderbilt Clinical Research Center, including baseline measurements and treatment days with either the active or sham binder, alongside standard care with midodrine. Blood pressure and heart rate will be monitored during various postural changes to assess orthostatic tolerance.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with neurogenic orthostatic hypotension and moderate to severe symptoms related to autonomic failure.

Not a fit: Patients with systemic illnesses causing autonomic neuropathy or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from orthostatic hypotension due to autonomic failure.

How similar studies have performed: While the approach of using an automated abdominal binder is novel, similar studies targeting orthostatic hypotension have shown promising results.

Eligibility criteria

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:

* 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

Where this trial is running

Nashville, Tennessee

• Autonomic Dysfunction Center/ Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Italo Biaggioni, MD — Professor of Medicine and Pharmacology
• Study coordinator: Bonnie K Black, RN

Conditions Orthostatic Hypotension; Autonomic Failure; Pure Autonomic Failure; Multiple System Atrophy; orthostatic hypotension; abdominal binder; pure autonomic failure; multiple system atrophy