Automated Abdominal Binder for Orthostatic Hypotension
Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure
About this trial
This is an interventional treatment trial for Orthostatic Hypotension focused on measuring orthostatic hypotension, abdominal binder, pure autonomic failure, multiple system atrophy
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
Sites / Locations
- Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Automated Abdominal Binder
Sham binder
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.
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.