Automated Abdominal Binder for Orthostatic Hypotension
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
Vanderbilt University Medical Center
31 participants
Mar 1, 2018
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
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.
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.
Oral placebo will be given three times a day on the baseline day (placebo)
A midodrine pill 10mg will be given three times a day on the standard of care study day
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03482297