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.
This is a randomized, double-blind, sham-controlled, parallel group study to compare the efficacy of the automated abdominal binder (inflated to 40 mm Hg) versus sham treatment (abdominal binder inflated to 5 mm Hg) in improving orthostatic tolerance in patients with primary autonomic failure disabled by orthostatic hypotension. Potential participants will be admitted to the Vanderbilt Clinical Research Center for evaluation of inclusion and exclusion criteria. Eligible patients will be randomized to the active or sham binder group. Patients will then be asked to participate 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 active or sham binder combined with placebo pill t.i.d. The order of the study days will be randomized. On each study day, blood pressure and heart rate will be measured while sitting, lying down, standing and walking during the Morning Orthostatic Trial, and posture and walking tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
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)
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGOrthostatic tolerance
orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials
Time frame: 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
Time frame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Upright time
Sum of standing and walking times
Time frame: After 10 minutes of standing and 15 minutes waking (as tolerated)
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A midodrine pill 10mg will be given three times a day on the standard of care study day