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

Trial ID: NCT03482297

Interventional - Phase 1/2 - Completed

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

Interventions

• automated abdominal binder
• Sham binder
• Placebo
• Midodrine

Eligibility

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

Sponsor

Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

Source: ClinicalTrials.gov

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