Study Summary
This trial is testing a device to help people with low blood pressure when standing up. The device is an abdominal binder that inflates automatically. The trial will test how well the device works and if it is safe.
Eligible Conditions
- Orthostatic Hypotension
- Pure Autonomic Failure
- Autonomic Failure
- Multiple System Atrophy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: After 10 minutes of standing and 15 minutes waking (as tolerated)
After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Orthostatic Hypotension Symptom Assessment (OHSA) Score
Orthostatic tolerance
After 10 minutes of standing and 15 minutes waking (as tolerated)
Upright time
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Automated Abdominal Binder
1 of 2
Sham binder
1 of 2
Experimental Treatment
Non-Treatment Group
31 Total Participants · 2 Treatment Groups
Primary Treatment: automated abdominal binder · Has Placebo Group · Phase 1 & 2
Automated Abdominal BinderExperimental Group · 3 Interventions: automated abdominal binder, Midodrine, Placebo · Intervention Types: Device, Drug, Drug
Sham binderShamComparator Group · 3 Interventions: Sham binder, Midodrine, Placebo · Intervention Types: Device, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midodrine
FDA approved
Placebo
1995
Completed Phase 3
~2670
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after 10 minutes of standing and 15 minutes waking (as tolerated)
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
774 Previous Clinical Trials
598,303 Total Patients Enrolled
5 Trials studying Orthostatic Hypotension
123 Patients Enrolled for Orthostatic Hypotension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,598 Previous Clinical Trials
46,956,403 Total Patients Enrolled
2 Trials studying Orthostatic Hypotension
37 Patients Enrolled for Orthostatic Hypotension
Luis E Okamoto, MDPrincipal Investigator - Research Assistant Professor
Vanderbilt University Medical Center
1 Previous Clinical Trials
29 Total Patients Enrolled
1 Trials studying Orthostatic Hypotension
29 Patients Enrolled for Orthostatic Hypotension
Italo Biaggioni, MDPrincipal InvestigatorProfessor of Medicine and Pharmacology
28 Previous Clinical Trials
1,437 Total Patients Enrolled
4 Trials studying Orthostatic Hypotension
502 Patients Enrolled for Orthostatic Hypotension
Eligibility Criteria
Age 40 - 80 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.
You have multiple systems atrophic and/or autonomic failure.
You are a male or female, age 40-80 years.
Who else is applying?
What state do they live in?
| Utah | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
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Conditions
Cancer Related
Treatments