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COMPLETED
NCT03482297
PHASE1/PHASE2

Automated Abdominal Binder for Orthostatic Hypotension

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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

28

Start Date

2018-03-01

Completion Date

2025-11-19

Last Updated

2026-05-05

Healthy Volunteers

No

Interventions

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

Locations (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States