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Automated Abdominal Binder for Orthostatic Hypotension

NCT03482297 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Italo Biaggioni, MD · Professor of Medicine and Pharmacology

  • Luis E Okamoto, MD · Research Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2025-11-19
Completion
2025-11-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482297 on ClinicalTrials.gov