Automated Abdominal Binder for Orthostatic Hypotension

Multiple System Atrophy Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Atrophy
• Autonomic Failure
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Orthostatic Hypotension
• Pure Autonomic Failure
• Shy-Drager Syndrome

• NCT number: NCT03482297
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Contact: Bonnie K Black, RN
• Phone: 615-343-6862
• Email: autonomics@vumc.org
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2018
• Completion date: December 1, 2024