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Automated Abdominal Binder for Orthostatic Hypotension
Sponsor: Vanderbilt University Medical Center
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2018-03-01
Completion Date
2026-12-01
Last Updated
2025-11-12
Healthy Volunteers
No
Interventions
automated abdominal binder
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.
Sham binder
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.
Placebo
Oral placebo will be given three times a day on the baseline day (placebo)
Midodrine
A midodrine pill 10mg will be given three times a day on the standard of care study day
Locations (1)
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States