NCT03482297

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Orthostatic Hypotension
• Autonomic Failure
• Pure Autonomic Failure
• Multiple System Atrophy

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
DRUG	Placebo	Oral placebo will be given three times a day on the baseline day (placebo)
DRUG	Midodrine	A midodrine pill 10mg will be given three times a day on the standard of care study day

Timeline

• Start date: 2018-03-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2018-03-29
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study